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+ ( Listing 16.2.8.1.5: Clinical Laboratory Data: Pregnancy Test)'
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+ ( All Randomized Analysis Set)'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( _______Collection________)'
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+ ( Analysis Time Serum beta hCG, Serum beta hCG, Follicle Stimulating)'
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+ (Visit Visit Date Day \(hh:mm\) Qualitative Quantitative \(mIU/mL\) Urine beta hCG Hormone \(mIU/mL\))'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( )'
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+ (Participant ID = 00310-10062 Trt = SBR Age/Sex/Race/Ethnicity = 51/F/BL/NH)'
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+ (First Dose = 2022-11-17 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
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+ (Screening Baseline 2022-10-27 \(-21\) 9:10 126.02)'
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+ ( )'
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+ (Participant ID = 00359-10124 Trt = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 57/F/BL/H)'
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+ (First Dose = 2023-01-24 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
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+ (Screening Baseline 2022-12-19 \(-36\) 8:30 121.27)'
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+ ( )'
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+ (Participant ID = 00947-10053 Trt = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 64/F/WH/H)'
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+ (First Dose = 2022-11-17 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
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+ (Screening Baseline 2022-10-21 \(-27\) 11:10 57.94)'
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+ ( )'
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+ (Participant ID = 00986-10127 Trt = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 37/F/BL/H)'
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+ (First Dose = 2023-01-24 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
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+ (Screening Baseline 2022-12-13 \(-42\) 11:05 Negative <0.6)'
56
+ (Day 1 Baseline 2023-01-24 \(1\) Negative)'
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+ ( )'
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+ (Participant ID = 01549-10089 Trt = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 69/F/BL/H)'
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+ (First Dose = 2022-12-15 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
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+ (Screening Baseline 2022-11-17 \(-28\) 11:28 Negative <0.6)'
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+ ( )'
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+ (Participant ID = 01609-10076 Trt = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 53/F/BL/NH)'
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+ (First Dose = 2022-12-08 Last Dose \(Study Day\) = Ongoing)'
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+ (Screening Baseline 2022-11-17 \(-21\) 12:35 125.14)'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ (AS = Asian; BL = Black; F = Female; M = Male; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline regimen; WH = White.)'
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+ (Day was the number of study days relative to the date of study Day 1.)'
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+ ($ Imputed last dose date for completely or partially missing last dose date.)'
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+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ (Participant ID = 01950-10002 Trt = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 60/M/BL/NH)'
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+ (First Dose = 2022-08-31 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
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+ (Unscheduled Baseline 2022-08-22 \(-9\) 12:44 19.14)'
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+ ( )'
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+ (Participant ID = 01950-10011 Trt = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 60/F/BL/NH)'
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+ (First Dose = 2022-10-05 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
102
+ (Screening Baseline 2022-09-20 \(-15\) 11:23 Negative 0.6)'
103
+ ( )'
104
+ (Participant ID = 05171-10031 Trt = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 26/F/BL/NH)'
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+ (First Dose = 2022-10-25 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
107
+ (Screening Baseline 2022-10-06 \(-19\) 16:55 Negative <0.6)'
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+ (Day 1 Baseline 2022-10-25 \(1\) Negative)'
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+ ( )'
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+ (Participant ID = 08888-10080 Trt = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 47/F/BL/NH)'
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+ (First Dose = 2022-12-13 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
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+ (Screening Baseline 2022-11-09 \(-34\) 11:30 42.57)'
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+ ( )'
115
+ (Participant ID = 14678-10097 Trt = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 56/M/WH/H)'
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+ (First Dose = 2022-12-21 Last Dose \(Study Day\) = Ongoing)'
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+ (Unscheduled Baseline 2022-12-13 \(-8\) 9:54 7.92)'
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+ ( )'
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+ (Participant ID = 25508-10083 Trt = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 53/F/WH/NH)'
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+ (First Dose = 2022-12-14 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
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+ (Screening Baseline 2022-11-29 \(-15\) 11:45 Negative 0.8)'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
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+ ( All Randomized Analysis Set)'
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+ ( )'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( )'
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+ ( Toxi-)'
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+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
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+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( )'
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+ (Participant ID = 00031-10072 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 70/M/WH/H)'
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+ (First Dose = 2022-12-05 Last Dose \(Study Day\) = Ongoing)'
50
+ ( )'
51
+ (Chemistry Serum Glucose \(Fasting\) 2022-11-09 \(-26\) 11:00 Screening Baseline 186 \(H\) mg/dL 70 - 100 Yes G2)'
52
+ ( 2022-12-05 \(1\) 10:00 Day 1 Baseline 110 \(H\) mg/dL 70 - 100 Yes G1)'
53
+ ( 2022-12-27 \(23\) 9:35 Week 4 Week 12 165 \(H\) mg/dL 70 - 100 Yes G2 ^)'
54
+ ( 2023-02-23 \(81\) 9:10 Week 12 Week 12 188 \(H\) mg/dL 70 - 100 Yes G2 ^)'
55
+ ( 2023-05-17 \(164\) 9:10 Week 24 Week 24 326 \(H\) mg/dL 70 - 100 Yes G3 *^)'
56
+ ( 2023-08-08 \(247\) 9:15 Week 36 Week 36 160 \(H\) mg/dL 70 - 100 Yes G2 ^)'
57
+ ( Serum Glucose \(Nonfasting\) 2023-05-25 \(172\) 10:15 Unscheduled Week 24 251 \(H\) mg/dL 70 - 100 No G3 *^#)'
58
+ ( )'
59
+ (Participant ID = 00310-10057 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 68/M/BL/NH)'
60
+ (First Dose = 2022-11-15 Last Dose \(Study Day\) = Ongoing)'
61
+ ( )'
62
+ (Chemistry Creatine Kinase \(CK\) 2022-10-24 \(-22\) 11:15 Screening Baseline 783 \(H\) U/L 39 - 308 Yes G0)'
63
+ ( 2022-11-15 \(1\) 9:10 Day 1 Baseline 1872 \(H\) U/L 39 - 308 Yes G2)'
64
+ ( 2022-12-13 \(29\) 9:20 Week 4 Week 4 1098 \(H\) U/L 39 - 308 No G1)'
65
+ ( 2023-02-10 \(88\) 10:46 Week 12 Week 12 3225 \(H\) U/L 39 - 308 Yes G3 *^)'
66
+ ( 2023-05-05 \(172\) 9:05 Week 24 Week 24 1089 \(H\) U/L 39 - 308 Yes G1)'
67
+ ( 2023-07-28 \(256\) 8:20 Week 36 Week 36 1636 \(H\) U/L 39 - 308 Yes G1)'
68
+ ( )'
69
+ (Participant ID = 00407-10014 Treatment = SBR Age/Sex/Race/Ethnicity = 58/M/BL/NH)'
70
+ (First Dose = 2022-10-10 Last Dose \(Study Day\) = Ongoing)'
71
+ ( )'
72
+ (Chemistry LDL \(Fasting\) 2022-10-10 \(1\) 8:10 Day 1 Baseline 151 \(H\) mg/dL <130 Yes G1)'
73
+ (______________________________________________________________________________________________________________________________________________________)'
74
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
75
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
76
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
77
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
78
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
79
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
80
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
81
+ ( )'
82
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
83
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 1 of 13)'
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+ ( Gilead Sciences, Inc.)'
94
+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
96
+ ( All Randomized Analysis Set)'
97
+ ( )'
98
+ (______________________________________________________________________________________________________________________________________________________)'
99
+ ( )'
100
+ ( Toxi-)'
101
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
102
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
103
+ (______________________________________________________________________________________________________________________________________________________)'
104
+ ( )'
105
+ (Chemistry LDL \(Fasting\) 2023-03-27 \(169\) 9:24 Week 24 Week 24 192 \(H\) mg/dL <130 Yes G3 *^)'
106
+ ( 2023-06-19 \(253\) 8:41 Week 36 Week 36 183 \(H\) mg/dL <130 Yes G2 ^)'
107
+ ( Total Cholesterol \(Fasting\) 2022-10-10 \(1\) 8:10 Day 1 Baseline 228 mg/dL 170 - 291 Yes G1)'
108
+ ( 2023-03-27 \(169\) 9:24 Week 24 Week 24 311 \(H\) mg/dL 170 - 291 Yes G3 *^)'
109
+ ( 2023-06-19 \(253\) 8:41 Week 36 Week 36 260 mg/dL 170 - 291 Yes G2 ^)'
110
+ ( )'
111
+ (Participant ID = 00407-10018 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 62/M/WH/H)'
112
+ (First Dose = 2022-10-12 Last Dose \(Study Day\) = Ongoing)'
113
+ ( )'
114
+ (Chemistry Serum Glucose \(Nonfasting\) 2022-09-15 \(-27\) 14:11 Screening Baseline 72 mg/dL 70 - 100 No G0)'
115
+ ( 2022-11-07 \(27\) 8:04 Week 4 Week 4 295 \(H\) mg/dL 70 - 100 No G3 *^#)'
116
+ ( 2022-11-28 \(48\) 8:24 Unscheduled Week 4 149 \(H\) mg/dL 70 - 100 No G1 ^)'
117
+ ( 2022-12-09 \(59\) 9:11 Unscheduled Week 12 153 \(H\) mg/dL 70 - 100 No G1 ^)'
118
+ (Urinalysis Urine Glucose 2022-09-15 \(-27\) 14:11 Screening Baseline Trace \(H\) NA No G1)'
119
+ ( 2022-10-12 \(1\) 8:48 Day 1 Baseline Normal NA Yes G0)'
120
+ ( 2022-11-07 \(27\) 8:04 Week 4 Week 4 +4 \(H\) NA No G3 *^#)'
121
+ ( 2022-11-28 \(48\) 8:24 Unscheduled Week 4 Normal NA No G0)'
122
+ ( 2022-12-09 \(59\) 9:11 Unscheduled Week 12 Normal NA No G0)'
123
+ ( 2023-01-04 \(85\) 8:50 Week 12 Week 12 Normal NA Yes G0)'
124
+ ( 2023-03-28 \(168\) 9:02 Week 24 Week 24 +3 \(H\) NA Yes G3 *^#)'
125
+ ( 2023-06-21 \(253\) 11:13 Week 36 Week 36 Normal NA Yes G0)'
126
+ ( )'
127
+ (Participant ID = 00698-10056 Treatment = SBR Age/Sex/Race/Ethnicity = 55/M/WH/NH)'
128
+ (First Dose = 2022-11-15 Last Dose \(Study Day\) = Ongoing)'
129
+ ( )'
130
+ (______________________________________________________________________________________________________________________________________________________)'
131
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
132
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
133
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
134
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
135
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
136
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
137
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
138
+ ( )'
139
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
140
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 2 of 13)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
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+ ( All Randomized Analysis Set)'
154
+ ( )'
155
+ (______________________________________________________________________________________________________________________________________________________)'
156
+ ( )'
157
+ ( Toxi-)'
158
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
159
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
160
+ (______________________________________________________________________________________________________________________________________________________)'
161
+ ( )'
162
+ (Chemistry LDL \(Fasting\) 2022-11-15 \(1\) 7:54 Day 1 Baseline 173 \(H\) mg/dL <130 Yes G2)'
163
+ ( 2023-02-07 \(85\) 7:25 Week 12 Week 12 204 \(H\) mg/dL <130 Yes G3 *^)'
164
+ ( 2023-05-02 \(169\) 7:25 Week 24 Week 24 79 mg/dL <130 Yes G0)'
165
+ ( 2023-07-25 \(253\) 7:38 Week 36 Week 36 82 mg/dL <130 Yes G0)'
166
+ ( Total Cholesterol \(Fasting\) 2022-11-15 \(1\) 7:54 Day 1 Baseline 281 mg/dL 170 - 291 Yes G2)'
167
+ ( 2023-02-07 \(85\) 7:25 Week 12 Week 12 300 \(H\) mg/dL 170 - 291 Yes G3 *^)'
168
+ ( 2023-05-02 \(169\) 7:25 Week 24 Week 24 150 \(L\) mg/dL 170 - 291 Yes G0)'
169
+ ( 2023-07-25 \(253\) 7:38 Week 36 Week 36 159 \(L\) mg/dL 170 - 291 Yes G0)'
170
+ ( )'
171
+ (Participant ID = 00777-10099 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 63/M/WH/NH)'
172
+ (First Dose = 2023-01-03 Last Dose \(Study Day\) = Ongoing)'
173
+ ( )'
174
+ (Chemistry Lipase 2022-12-16 \(-18\) 11:22 Screening Baseline 141 \(H\) U/L 0 - 120 No G1)'
175
+ ( 2023-01-03 \(1\) 9:05 Day 1 Baseline 532 \(H\) U/L 0 - 120 Yes G3)'
176
+ ( 2023-01-04 \(2\) 14:35 Unscheduled Week 4 474 \(H\) U/L 0 - 120 No G3)'
177
+ ( 2023-01-31 \(29\) 9:05 Week 4 Week 4 141 \(H\) U/L 0 - 120 Yes G1)'
178
+ ( 2023-03-30 \(87\) 9:10 Week 12 Week 12 287 \(H\) U/L 0 - 120 Yes G2)'
179
+ ( 2023-06-20 \(169\) 9:35 Week 24 Week 24 617 \(H\) U/L 0 - 120 Yes G4 *^)'
180
+ ( 2023-06-22 \(171\) 8:49 Unscheduled Week 24 148 \(H\) U/L 0 - 120 No G1)'
181
+ ( )'
182
+ (Participant ID = 00986-10125 Treatment = SBR Age/Sex/Race/Ethnicity = 57/F/BL/H)'
183
+ (First Dose = 2023-01-24 Last Dose \(Study Day\) = Ongoing)'
184
+ ( )'
185
+ (Chemistry Total Bilirubin 2022-12-13 \(-42\) 11:05 Screening Baseline 3.7 \(H\) mg/dL 0.2 - 1.2 Yes G3)'
186
+ ( 2023-01-03 \(-21\) 9:20 Unscheduled Baseline 2.7 \(H\) mg/dL 0.2 - 1.2 No G2)'
187
+ (______________________________________________________________________________________________________________________________________________________)'
188
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
189
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
190
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
191
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
192
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
193
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
194
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
195
+ ( )'
196
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
197
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 3 of 13)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
210
+ ( All Randomized Analysis Set)'
211
+ ( )'
212
+ (______________________________________________________________________________________________________________________________________________________)'
213
+ ( )'
214
+ ( Toxi-)'
215
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
216
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
217
+ (______________________________________________________________________________________________________________________________________________________)'
218
+ ( )'
219
+ (Chemistry Total Bilirubin 2023-01-24 \(1\) 10:00 Day 1 Baseline 2.7 \(H\) mg/dL 0.2 - 1.2 Yes G2)'
220
+ ( 2023-02-21 \(29\) 8:45 Week 4 Week 4 3.7 \(H\) mg/dL 0.2 - 1.2 Yes G3 *^)'
221
+ ( 2023-02-28 \(36\) 8:05 Unscheduled Week 4 2.8 \(H\) mg/dL 0.2 - 1.2 No G2)'
222
+ ( 2023-04-13 \(80\) 8:22 Week 12 Week 12 2.9 \(H\) mg/dL 0.2 - 1.2 Yes G2)'
223
+ ( 2023-07-06 \(164\) 7:55 Week 24 Week 24 3.3 \(H\) mg/dL 0.2 - 1.2 Yes G3 *^)'
224
+ ( 2023-07-19 \(177\) 9:15 Unscheduled Week 24 1.9 \(H\) mg/dL 0.2 - 1.2 No G1)'
225
+ ( )'
226
+ (Participant ID = 00986-10126 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 68/M/BL/NH)'
227
+ (First Dose = 2023-01-24 Last Dose \(Study Day\) = Ongoing)'
228
+ ( )'
229
+ (Chemistry Creatinine Clearance 2022-12-13 \(-42\) 11:12 Screening Baseline 56.2 \(L\) mL/min 85 - 125 Yes G3)'
230
+ ( 2023-01-24 \(1\) 9:55 Day 1 Baseline 64.6 \(L\) mL/min 85 - 125 Yes G2)'
231
+ ( 2023-02-21 \(29\) 8:58 Week 4 Week 4 55.7 \(L\) mL/min 85 - 125 Yes G3 *^)'
232
+ ( 2023-04-13 \(80\) 8:30 Week 12 Week 12 54.9 \(L\) mL/min 85 - 125 Yes G3 *^)'
233
+ ( 2023-07-06 \(164\) 7:50 Week 24 Week 24 57.7 \(L\) mL/min 85 - 125 Yes G3 *^)'
234
+ ( )'
235
+ (Participant ID = 00986-10127 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 37/F/BL/H)'
236
+ (First Dose = 2023-01-24 Last Dose \(Study Day\) = Ongoing)'
237
+ ( )'
238
+ (Chemistry Creatinine Clearance 2022-12-13 \(-42\) 11:05 Screening Baseline 69.1 \(L\) mL/min 75 - 115 Yes G2)'
239
+ ( 2023-01-24 \(1\) 12:40 Day 1 Baseline 64.1 \(L\) mL/min 75 - 115 Yes G2)'
240
+ ( 2023-02-21 \(29\) 8:55 Week 4 Week 4 53.3 \(L\) mL/min 75 - 115 Yes G3 *^)'
241
+ ( 2023-04-13 \(80\) 9:22 Week 12 Week 12 62.4 \(L\) mL/min 75 - 115 Yes G2)'
242
+ ( 2023-07-06 \(164\) 7:58 Week 24 Week 24 53.2 \(L\) mL/min 75 - 115 Yes G3 *^)'
243
+ ( )'
244
+ (______________________________________________________________________________________________________________________________________________________)'
245
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
246
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
247
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
248
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
249
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
250
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
251
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
252
+ ( )'
253
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
254
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 4 of 13)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
267
+ ( All Randomized Analysis Set)'
268
+ ( )'
269
+ (______________________________________________________________________________________________________________________________________________________)'
270
+ ( )'
271
+ ( Toxi-)'
272
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
273
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
274
+ (______________________________________________________________________________________________________________________________________________________)'
275
+ ( )'
276
+ (Participant ID = 00991-10032 Treatment = SBR Age/Sex/Race/Ethnicity = 54/M/WH/NH)'
277
+ (First Dose = 2022-10-26 Last Dose \(Study Day\) = Ongoing)'
278
+ ( )'
279
+ (Urinalysis Urine Glucose 2022-10-03 \(-23\) 9:55 Screening Baseline +1 \(H\) NA Yes G1)'
280
+ ( 2022-10-26 \(1\) 8:05 Day 1 Baseline Normal NA Yes G0)'
281
+ ( 2022-11-21 \(27\) 9:06 Week 4 Week 4 +3 \(H\) NA No G3 *^#)'
282
+ ( 2022-11-28 \(34\) 8:40 Unscheduled Week 4 Normal NA No G0)'
283
+ ( 2023-01-18 \(85\) 7:48 Week 12 Week 12 Normal NA Yes G0)'
284
+ ( 2023-04-12 \(169\) 7:58 Week 24 Week 24 Normal NA Yes G0)'
285
+ ( 2023-07-05 \(253\) 7:55 Week 36 Week 36 +1 \(H\) NA Yes G1 ^)'
286
+ ( )'
287
+ (Participant ID = 01598-10003 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 65/M/WH/NH)'
288
+ (First Dose = 2022-09-11 Last Dose \(Study Day\) = Ongoing)'
289
+ ( )'
290
+ (Chemistry Creatinine Clearance 2022-08-16 \(-26\) 11:30 Screening Baseline 71.8 \(L\) mL/min 85 - 125 Yes G2)'
291
+ ( 2022-09-11 \(1\) 8:10 Day 1 Baseline 63.5 \(L\) mL/min 85 - 125 Yes G2)'
292
+ ( 2022-10-10 \(30\) 8:25 Week 4 Week 4 56.8 \(L\) mL/min 85 - 125 Yes G3 *^)'
293
+ ( 2022-12-05 \(86\) 9:10 Week 12 Week 12 66.8 \(L\) mL/min 85 - 125 Yes G2)'
294
+ ( 2023-02-27 \(170\) 9:20 Week 24 Week 24 68.9 \(L\) mL/min 85 - 125 Yes G2)'
295
+ ( 2023-05-22 \(254\) 9:15 Week 36 Week 36 62.7 \(L\) mL/min 85 - 125 Yes G2)'
296
+ ( 2023-08-10 \(334\) 9:55 Week 48 Week 48 71.2 \(L\) mL/min 85 - 125 Yes G2)'
297
+ ( )'
298
+ (Participant ID = 01598-10015 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 66/M/WH/H)'
299
+ (First Dose = 2022-10-11 Last Dose \(Study Day\) = Ongoing)'
300
+ ( )'
301
+ (______________________________________________________________________________________________________________________________________________________)'
302
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
303
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
304
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
305
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
306
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
307
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
308
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
309
+ ( )'
310
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
311
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 5 of 13)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
323
+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
324
+ ( All Randomized Analysis Set)'
325
+ ( )'
326
+ (______________________________________________________________________________________________________________________________________________________)'
327
+ ( )'
328
+ ( Toxi-)'
329
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
330
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
331
+ (______________________________________________________________________________________________________________________________________________________)'
332
+ ( )'
333
+ (Urinalysis Urine Glucose 2022-09-08 \(-33\) 10:10 Screening Baseline Normal NA Yes G0)'
334
+ ( 2022-10-11 \(1\) 9:00 Day 1 Baseline Normal NA Yes G0)'
335
+ ( 2022-11-08 \(29\) 9:00 Week 4 Week 4 +4 \(H\) NA Yes G3 *^#)'
336
+ ( 2023-01-03 \(85\) 9:12 Week 12 Week 12 +4 \(H\) NA Yes G3 *^#)'
337
+ ( 2023-03-30 \(171\) 9:30 Week 24 Week 24 +4 \(H\) NA Yes G3 *^#)'
338
+ ( 2023-06-20 \(253\) 9:15 Week 36 Week 36 +4 \(H\) NA Yes G3 *^#)'
339
+ ( )'
340
+ (Participant ID = 01950-10017 Treatment = SBR Age/Sex/Race/Ethnicity = 59/M/WH/NH)'
341
+ (First Dose = 2022-10-11 Last Dose \(Study Day\) = Ongoing)'
342
+ ( )'
343
+ (Chemistry Serum Glucose \(Nonfasting\) 2022-09-19 \(-22\) 14:12 Screening Baseline 198 \(H\) mg/dL 70 - 100 No G2)'
344
+ ( 2022-11-08 \(29\) 10:30 Week 4 Week 4 316 \(H\) mg/dL 70 - 100 No G3 *^)'
345
+ ( )'
346
+ (Participant ID = 01966-10022 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 61/M/WH/NH)'
347
+ (First Dose = 2022-10-17 Last Dose \(Study Day\) = Ongoing)'
348
+ ( )'
349
+ (Chemistry Lipase 2022-09-15 \(-32\) 9:00 Screening Baseline 202 \(H\) U/L 0 - 120 Yes G2)'
350
+ ( 2022-10-17 \(1\) 8:31 Day 1 Baseline 71 U/L 0 - 120 Yes G0)'
351
+ ( 2022-11-15 \(30\) 8:42 Week 4 Week 4 75 U/L 0 - 120 Yes G0)'
352
+ ( 2023-01-10 \(86\) 8:25 Week 12 Week 12 51 U/L 0 - 120 Yes G0)'
353
+ ( 2023-04-10 \(176\) 8:40 Week 24 Week 24 75 U/L 0 - 120 Yes G0)'
354
+ ( 2023-06-26 \(253\) 8:40 Week 36 Week 36 420 \(H\) U/L 0 - 120 Yes G3 *^#)'
355
+ ( )'
356
+ ( )'
357
+ ( )'
358
+ (______________________________________________________________________________________________________________________________________________________)'
359
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
360
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
361
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
362
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
363
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
364
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
365
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
366
+ ( )'
367
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
368
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 6 of 13)'
369
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+ ( Gilead Sciences, Inc.)'
379
+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
380
+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
381
+ ( All Randomized Analysis Set)'
382
+ ( )'
383
+ (______________________________________________________________________________________________________________________________________________________)'
384
+ ( )'
385
+ ( Toxi-)'
386
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
387
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
388
+ (______________________________________________________________________________________________________________________________________________________)'
389
+ ( )'
390
+ (Participant ID = 02058-10029 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 59/M/WH/NH)'
391
+ (First Dose = 2022-10-24 Last Dose \(Study Day\) = Ongoing)'
392
+ ( )'
393
+ (Chemistry Lipase 2022-09-28 \(-26\) 14:49 Screening Baseline 165 \(H\) U/L 0 - 100 No G2)'
394
+ ( 2022-10-24 \(1\) 9:49 Day 1 Baseline 78 U/L 0 - 100 No G0)'
395
+ ( 2022-11-15 \(23\) 8:55 Week 4 Week 4 173 \(H\) U/L 0 - 100 Yes G2 ^)'
396
+ ( 2023-01-16 \(85\) 8:56 Week 12 Week 12 364 \(H\) U/L 0 - 100 Yes G3 *^#)'
397
+ ( 2023-04-04 \(163\) 9:42 Week 24 Week 24 78 U/L 0 - 100 Yes G0)'
398
+ ( 2023-06-27 \(247\) 8:30 Week 36 Week 36 74 U/L 0 - 100 Yes G0)'
399
+ ( )'
400
+ (Participant ID = 02058-10034 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 55/M/WH/NH)'
401
+ (First Dose = 2022-10-26 Last Dose \(Study Day\) = Ongoing)'
402
+ ( )'
403
+ (Chemistry Serum Glucose \(Nonfasting\) 2022-09-27 \(-29\) 14:00 Screening Baseline 158 \(H\) mg/dL 70 - 100 No G1)'
404
+ ( 2023-07-10 \(258\) 10:41 Week 36 Week 36 318 \(H\) mg/dL 70 - 100 No G3 *^)'
405
+ ( )'
406
+ (Participant ID = 02106-10009 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 64/F/BL/NH)'
407
+ (First Dose = 2022-09-29 Last Dose \(Study Day\) = Ongoing)'
408
+ ( )'
409
+ (Chemistry Creatinine 2022-09-14 \(-15\) 11:48 Screening Baseline 2.54 \(H\) mg/dL 0.35 - 1.14 No G3)'
410
+ ( 2022-09-29 \(1\) 10:08 Day 1 Baseline 1.99 \(H\) mg/dL 0.35 - 1.14 Yes G2)'
411
+ ( 2022-10-27 \(29\) 9:07 Week 4 Week 4 2.40 \(H\) mg/dL 0.35 - 1.14 Yes G3 *^)'
412
+ ( 2022-12-19 \(82\) 11:24 Week 12 Week 12 2.34 \(H\) mg/dL 0.35 - 1.14 Yes G3 *^)'
413
+ ( 2023-03-13 \(166\) 10:35 Week 24 Week 24 3.35 \(H\) mg/dL 0.35 - 1.14 Yes G3 *^)'
414
+ ( 2023-04-03 \(187\) 10:12 Unscheduled Week 24 3.27 \(H\) mg/dL 0.35 - 1.14 No G3 *^)'
415
+ (______________________________________________________________________________________________________________________________________________________)'
416
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
417
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
418
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
419
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
420
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
421
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
422
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
423
+ ( )'
424
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
425
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 7 of 13)'
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+ ( Gilead Sciences, Inc.)'
436
+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
437
+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
438
+ ( All Randomized Analysis Set)'
439
+ ( )'
440
+ (______________________________________________________________________________________________________________________________________________________)'
441
+ ( )'
442
+ ( Toxi-)'
443
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
444
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
445
+ (______________________________________________________________________________________________________________________________________________________)'
446
+ ( )'
447
+ (Chemistry Creatinine 2023-06-12 \(257\) 10:50 Week 36 Week 36 3.10 \(H\) mg/dL 0.35 - 1.14 Yes G3 *^)'
448
+ ( Creatinine Clearance 2022-09-14 \(-15\) 11:48 Screening Baseline 28.1 \(L\) mL/min 75 - 115 No G4)'
449
+ ( 2022-09-29 \(1\) 10:08 Day 1 Baseline 35.1 \(L\) mL/min 75 - 115 Yes G3)'
450
+ ( 2022-10-27 \(29\) 9:07 Week 4 Week 4 29.6 \(L\) mL/min 75 - 115 Yes G4 *^)'
451
+ ( 2022-12-19 \(82\) 11:24 Week 12 Week 12 30.4 \(L\) mL/min 75 - 115 Yes G3)'
452
+ ( 2023-03-13 \(166\) 10:35 Week 24 Week 24 21.0 \(L\) mL/min 75 - 115 Yes G4 *^)'
453
+ ( 2023-04-03 \(187\) 10:12 Unscheduled Week 24 21.4 \(L\) mL/min 75 - 115 No G4 *^)'
454
+ ( 2023-06-12 \(257\) 10:50 Week 36 Week 36 23.2 \(L\) mL/min 75 - 115 Yes G4 *^)'
455
+ (Urinalysis Urine Glucose 2022-09-14 \(-15\) 11:48 Screening Baseline Normal NA No G0)'
456
+ ( 2022-09-29 \(1\) 10:08 Day 1 Baseline Normal NA Yes G0)'
457
+ ( 2022-10-27 \(29\) 9:07 Week 4 Week 4 Normal NA Yes G0)'
458
+ ( 2022-12-19 \(82\) 11:24 Week 12 Week 12 Normal NA Yes G0)'
459
+ ( 2023-03-13 \(166\) 10:35 Week 24 Week 24 +3 \(H\) NA Yes G3 *^#)'
460
+ ( 2023-06-12 \(257\) 10:50 Week 36 Week 36 +4 \(H\) NA Yes G3 *^#)'
461
+ ( )'
462
+ (Participant ID = 02106-10013 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 68/F/BL/NH)'
463
+ (First Dose = 2022-10-05 Last Dose \(Study Day\) = Ongoing)'
464
+ ( )'
465
+ (Urinalysis Urine Glucose 2022-09-22 \(-13\) 11:26 Screening Baseline +4 \(H\) NA No G3)'
466
+ ( 2022-10-05 \(1\) 8:51 Day 1 Baseline +2 \(H\) NA Yes G2)'
467
+ ( 2022-11-02 \(29\) 8:20 Week 4 Week 4 +2 \(H\) NA Yes G2)'
468
+ ( 2022-12-29 \(86\) 8:49 Unscheduled Week 12 +4 \(H\) NA No G3 *^)'
469
+ ( 2023-03-16 \(163\) 8:26 Week 24 Week 24 +2 \(H\) NA Yes G2)'
470
+ ( 2023-03-23 \(170\) 8:58 Unscheduled Week 24 Normal NA No G0)'
471
+ ( 2023-06-12 \(251\) 9:47 Week 36 Week 36 Normal NA Yes G0)'
472
+ (______________________________________________________________________________________________________________________________________________________)'
473
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
474
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
475
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
476
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
477
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
478
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
479
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
480
+ ( )'
481
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
482
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 8 of 13)'
483
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+ ( Gilead Sciences, Inc.)'
493
+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
494
+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
495
+ ( All Randomized Analysis Set)'
496
+ ( )'
497
+ (______________________________________________________________________________________________________________________________________________________)'
498
+ ( )'
499
+ ( Toxi-)'
500
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
501
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
502
+ (______________________________________________________________________________________________________________________________________________________)'
503
+ ( )'
504
+ (Participant ID = 02728-10065 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 58/M/AS/NH)'
505
+ (First Dose = 2022-11-18 Last Dose \(Study Day\) = Ongoing)'
506
+ ( )'
507
+ (Chemistry Serum Glucose \(Nonfasting\) 2023-05-04 \(168\) 10:00 Unscheduled Week 24 255 \(H\) mg/dL 70 - 100 No G3 *^#)'
508
+ ( )'
509
+ (Participant ID = 02854-10059 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 65/M/WH/NH)'
510
+ (First Dose = 2022-11-16 Last Dose \(Study Day\) = Ongoing)'
511
+ ( )'
512
+ (Chemistry Triglycerides \(Fasting\) 2022-11-16 \(1\) 10:25 Day 1 Baseline 424 \(H\) mg/dL 58 - 260 Yes G2)'
513
+ ( 2023-02-09 \(86\) 10:58 Week 12 Week 12 326 \(H\) mg/dL 58 - 260 Yes G2)'
514
+ ( 2023-05-03 \(169\) 10:45 Week 24 Week 24 857 \(H\) mg/dL 58 - 260 Yes G3 *^)'
515
+ ( 2023-07-19 \(246\) 11:20 Week 36 Week 36 610 \(H\) mg/dL 58 - 260 Yes G3 *^)'
516
+ ( )'
517
+ (Participant ID = 02854-10078 Treatment = SBR Age/Sex/Race/Ethnicity = 64/M/WH/NH)'
518
+ (First Dose = 2022-12-12 Last Dose \(Study Day\) = Ongoing)'
519
+ ( )'
520
+ (Chemistry Creatinine Clearance 2022-11-21 \(-21\) 10:20 Screening Baseline 69.5 \(L\) mL/min 85 - 125 No G2)'
521
+ ( 2022-12-12 \(1\) 8:40 Day 1 Baseline 62.5 \(L\) mL/min 85 - 125 Yes G2)'
522
+ ( 2023-01-05 \(25\) 9:15 Week 4 Week 4 65.0 \(L\) mL/min 85 - 125 Yes G2)'
523
+ ( 2023-03-09 \(88\) 9:19 Week 12 Week 12 66.3 \(L\) mL/min 85 - 125 Yes G2)'
524
+ ( 2023-05-30 \(170\) 11:00 Week 24 Week 24 59.7 \(L\) mL/min 85 - 125 Yes G3 *^)'
525
+ ( 2023-06-13 \(184\) 12:40 Unscheduled Week 24 70.6 \(L\) mL/min 85 - 125 No G2)'
526
+ ( 2023-08-16 \(248\) 9:22 Week 36 Week 36 62.3 \(L\) mL/min 85 - 125 Yes G2)'
527
+ ( )'
528
+ ( )'
529
+ (______________________________________________________________________________________________________________________________________________________)'
530
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
531
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
532
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
533
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
534
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
535
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
536
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
537
+ ( )'
538
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
539
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 9 of 13)'
540
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+ ( Gilead Sciences, Inc.)'
550
+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
551
+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
552
+ ( All Randomized Analysis Set)'
553
+ ( )'
554
+ (______________________________________________________________________________________________________________________________________________________)'
555
+ ( )'
556
+ ( Toxi-)'
557
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
558
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
559
+ (______________________________________________________________________________________________________________________________________________________)'
560
+ ( )'
561
+ (Participant ID = 04170-10101 Treatment = SBR Age/Sex/Race/Ethnicity = 64/M/WH/NH)'
562
+ (First Dose = 2023-01-04 Last Dose \(Study Day\) = Ongoing)'
563
+ ( )'
564
+ (Chemistry Creatinine Clearance 2022-11-25 \(-40\) 11:20 Screening Baseline 74.2 \(L\) mL/min 85 - 125 Yes G2)'
565
+ ( 2023-01-04 \(1\) 12:40 Day 1 Baseline 67.2 \(L\) mL/min 85 - 125 Yes G2)'
566
+ ( 2023-01-18 \(15\) 14:40 Week 4 Week 4 73.8 \(L\) mL/min 85 - 125 Yes G2)'
567
+ ( 2023-03-29 \(85\) 15:15 Week 12 Week 12 45.3 \(L\) mL/min 85 - 125 Yes G3 *^)'
568
+ ( 2023-04-05 \(92\) 15:15 Unscheduled Week 12 64.8 \(L\) mL/min 85 - 125 No G2)'
569
+ ( 2023-06-21 \(169\) 12:15 Week 24 Week 24 76.7 \(L\) mL/min 85 - 125 Yes G2)'
570
+ ( )'
571
+ (Participant ID = 04170-10110 Treatment = SBR Age/Sex/Race/Ethnicity = 65/M/WH/NH)'
572
+ (First Dose = 2023-01-11 Last Dose \(Study Day\) = Ongoing)'
573
+ ( )'
574
+ (Chemistry Creatinine Clearance 2022-11-29 \(-43\) 10:40 Screening Baseline 87.6 mL/min 85 - 125 Yes G2)'
575
+ ( 2023-01-11 \(1\) 11:35 Day 1 Baseline 103.0 mL/min 85 - 125 Yes G0)'
576
+ ( 2023-02-09 \(30\) 10:10 Week 4 Week 4 80.6 \(L\) mL/min 85 - 125 Yes G2 ^)'
577
+ ( 2023-04-06 \(86\) 15:50 Week 12 Week 12 87.6 mL/min 85 - 125 Yes G2 ^)'
578
+ ( 2023-06-29 \(170\) 15:10 Week 24 Week 24 71.4 \(L\) mL/min 85 - 125 Yes G3 *^#)'
579
+ ( )'
580
+ (Participant ID = 08888-10080 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 47/F/BL/NH)'
581
+ (First Dose = 2022-12-13 Last Dose \(Study Day\) = Ongoing)'
582
+ ( )'
583
+ (Urinalysis Urine Glucose 2022-11-09 \(-34\) 11:30 Screening Baseline +4 \(H\) NA No G3)'
584
+ ( 2022-12-13 \(1\) 8:15 Day 1 Baseline +2 \(H\) NA Yes G2)'
585
+ ( 2023-01-11 \(30\) 8:29 Week 4 Week 4 Trace \(H\) NA Yes G1)'
586
+ (______________________________________________________________________________________________________________________________________________________)'
587
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
588
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
589
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
590
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
591
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
592
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
593
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
594
+ ( )'
595
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
596
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 10 of 13)'
597
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+ ( Gilead Sciences, Inc.)'
607
+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
608
+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
609
+ ( All Randomized Analysis Set)'
610
+ ( )'
611
+ (______________________________________________________________________________________________________________________________________________________)'
612
+ ( )'
613
+ ( Toxi-)'
614
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
615
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
616
+ (______________________________________________________________________________________________________________________________________________________)'
617
+ ( )'
618
+ (Urinalysis Urine Glucose 2023-03-08 \(86\) 8:12 Week 12 Week 12 +4 \(H\) NA Yes G3 *^)'
619
+ ( 2023-05-30 \(169\) 8:25 Week 24 Week 24 +4 \(H\) NA Yes G3 *^)'
620
+ ( 2023-06-06 \(176\) 8:50 Unscheduled Week 24 +4 \(H\) NA No G3 *^)'
621
+ ( )'
622
+ (Participant ID = 17068-10121 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 79/M/BL/NH)'
623
+ (First Dose = 2023-01-20 Last Dose \(Study Day\) = Ongoing)'
624
+ ( )'
625
+ (Chemistry Creatinine Clearance 2022-12-13 \(-38\) 11:25 Screening Baseline 32.4 \(L\) mL/min 85 - 125 No G3)'
626
+ ( 2023-01-20 \(1\) 11:40 Day 1 Baseline 36.1 \(L\) mL/min 85 - 125 Yes G3)'
627
+ ( 2023-02-16 \(28\) 13:15 Week 4 Week 4 25.2 \(L\) mL/min 85 - 125 No G4 *^)'
628
+ ( 2023-03-01 \(41\) 10:05 Unscheduled Week 4 28.4 \(L\) mL/min 85 - 125 No G4 *^)'
629
+ ( 2023-04-12 \(83\) 13:18 Week 12 Week 12 23.3 \(L\) mL/min 85 - 125 Yes G4 *^)'
630
+ ( 2023-04-25 \(96\) 15:40 Unscheduled Week 12 26.2 \(L\) mL/min 85 - 125 No G4 *^)'
631
+ ( 2023-07-05 \(167\) 11:02 Week 24 Week 24 29.6 \(L\) mL/min 85 - 125 Yes G4 *^)'
632
+ ( )'
633
+ (Participant ID = 25207-10043 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 72/M/WH/NP)'
634
+ (First Dose = 2022-11-03 Last Dose \(Study Day\) = Ongoing)'
635
+ ( )'
636
+ (Chemistry Creatinine Clearance 2022-10-31 \(-3\) 11:00 Screening Baseline 63.9 \(L\) mL/min 85 - 125 Yes G2)'
637
+ ( 2022-11-03 \(1\) 10:25 Day 1 Baseline 62.9 \(L\) mL/min 85 - 125 Yes G2)'
638
+ ( 2022-12-01 \(29\) 10:30 Week 4 Week 4 21.1 \(L\) mL/min 85 - 125 No G4 *^)'
639
+ ( 2022-12-06 \(34\) 9:30 Unscheduled Week 4 59.9 \(L\) mL/min 85 - 125 No G3 ^)'
640
+ ( 2023-01-26 \(85\) 7:00 Week 12 Week 12 69.1 \(L\) mL/min 85 - 125 Yes G2)'
641
+ ( 2023-04-21 \(170\) 8:45 Week 24 Week 24 61.4 \(L\) mL/min 85 - 125 Yes G2)'
642
+ ( 2023-04-25 \(174\) 7:50 Unscheduled Week 24 64.5 \(L\) mL/min 85 - 125 No G2)'
643
+ (______________________________________________________________________________________________________________________________________________________)'
644
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
645
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
646
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
647
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
648
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
649
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
650
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
651
+ ( )'
652
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
653
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 11 of 13)'
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+ ( Gilead Sciences, Inc.)'
664
+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
665
+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
666
+ ( All Randomized Analysis Set)'
667
+ ( )'
668
+ (______________________________________________________________________________________________________________________________________________________)'
669
+ ( )'
670
+ ( Toxi-)'
671
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
672
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
673
+ (______________________________________________________________________________________________________________________________________________________)'
674
+ ( )'
675
+ (Chemistry Creatinine Clearance 2023-07-17 \(257\) 11:00 Week 36 Week 36 60.6 \(L\) mL/min 85 - 125 Yes G2)'
676
+ (Urinalysis Urine Glucose 2022-10-31 \(-3\) 11:00 Screening Baseline Trace \(H\) NA Yes G1)'
677
+ ( 2022-11-03 \(1\) 10:25 Day 1 Baseline Normal NA Yes G0)'
678
+ ( 2022-12-01 \(29\) 10:30 Week 4 Week 4 +4 \(H\) NA No G3 *^#)'
679
+ ( 2023-01-26 \(85\) 7:00 Week 12 Week 12 +4 \(H\) NA Yes G3 *^#)'
680
+ ( 2023-04-21 \(170\) 8:45 Week 24 Week 24 +4 \(H\) NA Yes G3 *^#)'
681
+ ( 2023-07-17 \(257\) 11:00 Week 36 Week 36 +4 \(H\) NA Yes G3 *^#)'
682
+ ( )'
683
+ (Participant ID = 25207-10063 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 57/M/AS/NH)'
684
+ (First Dose = 2022-11-18 Last Dose \(Study Day\) = Ongoing)'
685
+ ( )'
686
+ (Chemistry Creatinine Clearance 2022-10-21 \(-28\) 9:50 Screening Baseline 50.1 \(L\) mL/min 85 - 125 No G3)'
687
+ ( 2022-11-18 \(1\) 8:40 Day 1 Baseline 61.2 \(L\) mL/min 85 - 125 Yes G2)'
688
+ ( 2022-12-16 \(29\) 8:20 Week 4 Week 4 55.8 \(L\) mL/min 85 - 125 Yes G3 *^)'
689
+ ( 2023-02-10 \(85\) 7:25 Week 12 Week 12 57.2 \(L\) mL/min 85 - 125 No G3 *^)'
690
+ ( 2023-05-05 \(169\) 8:50 Week 24 Week 24 60.2 \(L\) mL/min 85 - 125 Yes G2)'
691
+ ( 2023-08-01 \(257\) 8:50 Week 36 Week 36 54.3 \(L\) mL/min 85 - 125 No G3 *^)'
692
+ ( Serum Glucose \(Nonfasting\) 2022-10-21 \(-28\) 9:50 Screening Baseline 165 \(H\) mg/dL 70 - 100 No G2)'
693
+ ( 2023-02-10 \(85\) 7:25 Week 12 Week 12 293 \(H\) mg/dL 70 - 100 No G3 *^)'
694
+ ( 2023-08-01 \(257\) 8:50 Week 36 Week 36 238 \(H\) mg/dL 70 - 100 No G2)'
695
+ ( )'
696
+ (Participant ID = 25207-10105 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 62/M/WH/NH)'
697
+ (First Dose = 2023-01-09 Last Dose \(Study Day\) = 2023-05-02 \(114\))'
698
+ ( )'
699
+ (Chemistry Serum Glucose \(Fasting\) 2022-12-08 \(-32\) 13:20 Screening Baseline 150 \(H\) mg/dL 70 - 100 Yes G2)'
700
+ (______________________________________________________________________________________________________________________________________________________)'
701
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
702
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
703
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
704
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
705
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
706
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
707
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
708
+ ( )'
709
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
710
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 12 of 13)'
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+ ( Gilead Sciences, Inc.)'
721
+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
722
+ ( Listing 16.2.8.1.6.2: Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities)'
723
+ ( All Randomized Analysis Set)'
724
+ ( )'
725
+ (______________________________________________________________________________________________________________________________________________________)'
726
+ ( )'
727
+ ( Toxi-)'
728
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
729
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
730
+ (______________________________________________________________________________________________________________________________________________________)'
731
+ ( )'
732
+ (Chemistry Serum Glucose \(Fasting\) 2023-01-09 \(1\) 8:30 Day 1 Baseline 150 \(H\) mg/dL 70 - 100 Yes G2)'
733
+ ( 2023-02-07 \(30\) 9:45 Week 4 Week 12 217 \(H\) mg/dL 70 - 100 Yes G2)'
734
+ ( 2023-04-04 \(86\) 10:15 Week 12 Week 12 196 \(H\) mg/dL 70 - 100 Yes G2)'
735
+ ( 2023-05-04 \(116\) 9:15 ESDD Week 12 297 \(H\) mg/dL 70 - 100 Yes G3 *^)'
736
+ (Urinalysis Urine Glucose 2022-12-08 \(-32\) 13:20 Screening Baseline +3 \(H\) NA Yes G3)'
737
+ ( 2023-01-09 \(1\) 8:30 Day 1 Baseline Normal NA Yes G0)'
738
+ ( 2023-02-07 \(30\) 9:45 Week 4 Week 4 +3 \(H\) NA Yes G3 *^#)'
739
+ ( 2023-04-04 \(86\) 10:15 Week 12 Week 12 +2 \(H\) NA Yes G2 ^)'
740
+ ( 2023-05-04 \(116\) 9:15 ESDD Week 12 +4 \(H\) NA Yes G3 *^#)'
741
+ ( )'
742
+ (Participant ID = 25508-10083 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 53/F/WH/NH)'
743
+ (First Dose = 2022-12-14 Last Dose \(Study Day\) = Ongoing)'
744
+ ( )'
745
+ (Chemistry Serum Glucose \(Nonfasting\) 2023-01-11 \(29\) 10:31 Week 4 Week 4 275 \(H\) mg/dL 70 - 100 No G3 *^#)'
746
+ ( 2023-03-07 \(84\) 10:15 Week 12 Week 12 160 \(H\) mg/dL 70 - 100 No G1 ^)'
747
+ ( )'
748
+ ( )'
749
+ ( )'
750
+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
757
+ (______________________________________________________________________________________________________________________________________________________)'
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+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
759
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
760
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
761
+ (A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and)'
762
+ (including last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR Group\).)'
763
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
764
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
765
+ ( )'
766
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
767
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-g34.pdf 12APR2024: 9:02 Page 13 of 13)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.1.7: Treatment-Emergent Marked Laboratory Abnormalities)'
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+ ( All Randomized Analysis Set)'
32
+ ( )'
33
+ (______________________________________________________________________________________________________________________________________________________)'
34
+ ( )'
35
+ ( Toxi-)'
36
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
37
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
38
+ (______________________________________________________________________________________________________________________________________________________)'
39
+ ( )'
40
+ (Participant ID = 00031-10072 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 70/M/WH/H)'
41
+ (First Dose = 2022-12-05 Last Dose \(Study Day\) = Ongoing)'
42
+ ( )'
43
+ (Chemistry Serum Glucose \(Nonfasting\) 2023-05-25 \(172\) 10:15 Unscheduled Week 24 251 \(H\) mg/dL 70 - 100 No G3 *^#)'
44
+ ( )'
45
+ (Participant ID = 00407-10018 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 62/M/WH/H)'
46
+ (First Dose = 2022-10-12 Last Dose \(Study Day\) = Ongoing)'
47
+ ( )'
48
+ (Chemistry Serum Glucose \(Nonfasting\) 2022-09-15 \(-27\) 14:11 Screening Baseline 72 mg/dL 70 - 100 No G0)'
49
+ ( 2022-11-07 \(27\) 8:04 Week 4 Week 4 295 \(H\) mg/dL 70 - 100 No G3 *^#)'
50
+ ( 2022-11-28 \(48\) 8:24 Unscheduled Week 4 149 \(H\) mg/dL 70 - 100 No G1 ^)'
51
+ ( 2022-12-09 \(59\) 9:11 Unscheduled Week 12 153 \(H\) mg/dL 70 - 100 No G1 ^)'
52
+ (Urinalysis Urine Glucose 2022-09-15 \(-27\) 14:11 Screening Baseline Trace \(H\) NA No G1)'
53
+ ( 2022-10-12 \(1\) 8:48 Day 1 Baseline Normal NA Yes G0)'
54
+ ( 2022-11-07 \(27\) 8:04 Week 4 Week 4 +4 \(H\) NA No G3 *^#)'
55
+ ( 2022-11-28 \(48\) 8:24 Unscheduled Week 4 Normal NA No G0)'
56
+ ( 2022-12-09 \(59\) 9:11 Unscheduled Week 12 Normal NA No G0)'
57
+ ( 2023-01-04 \(85\) 8:50 Week 12 Week 12 Normal NA Yes G0)'
58
+ ( 2023-03-28 \(168\) 9:02 Week 24 Week 24 +3 \(H\) NA Yes G3 *^#)'
59
+ ( 2023-06-21 \(253\) 11:13 Week 36 Week 36 Normal NA Yes G0)'
60
+ ( )'
61
+ (Participant ID = 00991-10032 Treatment = SBR Age/Sex/Race/Ethnicity = 54/M/WH/NH)'
62
+ (First Dose = 2022-10-26 Last Dose \(Study Day\) = Ongoing)'
63
+ ( )'
64
+ (Urinalysis Urine Glucose 2022-10-03 \(-23\) 9:55 Screening Baseline +1 \(H\) NA Yes G1)'
65
+ (______________________________________________________________________________________________________________________________________________________)'
66
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
67
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
68
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
69
+ (A treatment-emergent marked laboratory abnormality was defined as an increase of at least 3 toxicity grades from baseline at any postbaseline time)'
70
+ (point, up to and including the last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR group\).)'
71
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
72
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
73
+ ( )'
74
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
75
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-mark.pdf 12APR2024: 9:02 Page 1 of 5)'
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+ ( Gilead Sciences, Inc.)'
86
+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
87
+ ( Listing 16.2.8.1.7: Treatment-Emergent Marked Laboratory Abnormalities)'
88
+ ( All Randomized Analysis Set)'
89
+ ( )'
90
+ (______________________________________________________________________________________________________________________________________________________)'
91
+ ( )'
92
+ ( Toxi-)'
93
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
94
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
95
+ (______________________________________________________________________________________________________________________________________________________)'
96
+ ( )'
97
+ (Urinalysis Urine Glucose 2022-10-26 \(1\) 8:05 Day 1 Baseline Normal NA Yes G0)'
98
+ ( 2022-11-21 \(27\) 9:06 Week 4 Week 4 +3 \(H\) NA No G3 *^#)'
99
+ ( 2022-11-28 \(34\) 8:40 Unscheduled Week 4 Normal NA No G0)'
100
+ ( 2023-01-18 \(85\) 7:48 Week 12 Week 12 Normal NA Yes G0)'
101
+ ( 2023-04-12 \(169\) 7:58 Week 24 Week 24 Normal NA Yes G0)'
102
+ ( 2023-07-05 \(253\) 7:55 Week 36 Week 36 +1 \(H\) NA Yes G1 ^)'
103
+ ( )'
104
+ (Participant ID = 01598-10015 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 66/M/WH/H)'
105
+ (First Dose = 2022-10-11 Last Dose \(Study Day\) = Ongoing)'
106
+ ( )'
107
+ (Urinalysis Urine Glucose 2022-09-08 \(-33\) 10:10 Screening Baseline Normal NA Yes G0)'
108
+ ( 2022-10-11 \(1\) 9:00 Day 1 Baseline Normal NA Yes G0)'
109
+ ( 2022-11-08 \(29\) 9:00 Week 4 Week 4 +4 \(H\) NA Yes G3 *^#)'
110
+ ( 2023-01-03 \(85\) 9:12 Week 12 Week 12 +4 \(H\) NA Yes G3 *^#)'
111
+ ( 2023-03-30 \(171\) 9:30 Week 24 Week 24 +4 \(H\) NA Yes G3 *^#)'
112
+ ( 2023-06-20 \(253\) 9:15 Week 36 Week 36 +4 \(H\) NA Yes G3 *^#)'
113
+ ( )'
114
+ (Participant ID = 01966-10022 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 61/M/WH/NH)'
115
+ (First Dose = 2022-10-17 Last Dose \(Study Day\) = Ongoing)'
116
+ ( )'
117
+ (Chemistry Lipase 2022-09-15 \(-32\) 9:00 Screening Baseline 202 \(H\) U/L 0 - 120 Yes G2)'
118
+ ( 2022-10-17 \(1\) 8:31 Day 1 Baseline 71 U/L 0 - 120 Yes G0)'
119
+ ( 2022-11-15 \(30\) 8:42 Week 4 Week 4 75 U/L 0 - 120 Yes G0)'
120
+ ( 2023-01-10 \(86\) 8:25 Week 12 Week 12 51 U/L 0 - 120 Yes G0)'
121
+ ( 2023-04-10 \(176\) 8:40 Week 24 Week 24 75 U/L 0 - 120 Yes G0)'
122
+ (______________________________________________________________________________________________________________________________________________________)'
123
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
124
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
125
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
126
+ (A treatment-emergent marked laboratory abnormality was defined as an increase of at least 3 toxicity grades from baseline at any postbaseline time)'
127
+ (point, up to and including the last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR group\).)'
128
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
129
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
130
+ ( )'
131
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
132
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-mark.pdf 12APR2024: 9:02 Page 2 of 5)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.1.7: Treatment-Emergent Marked Laboratory Abnormalities)'
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+ ( All Randomized Analysis Set)'
146
+ ( )'
147
+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( )'
149
+ ( Toxi-)'
150
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
151
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
152
+ (______________________________________________________________________________________________________________________________________________________)'
153
+ ( )'
154
+ (Chemistry Lipase 2023-06-26 \(253\) 8:40 Week 36 Week 36 420 \(H\) U/L 0 - 120 Yes G3 *^#)'
155
+ ( )'
156
+ (Participant ID = 02058-10029 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 59/M/WH/NH)'
157
+ (First Dose = 2022-10-24 Last Dose \(Study Day\) = Ongoing)'
158
+ ( )'
159
+ (Chemistry Lipase 2022-09-28 \(-26\) 14:49 Screening Baseline 165 \(H\) U/L 0 - 100 No G2)'
160
+ ( 2022-10-24 \(1\) 9:49 Day 1 Baseline 78 U/L 0 - 100 No G0)'
161
+ ( 2022-11-15 \(23\) 8:55 Week 4 Week 4 173 \(H\) U/L 0 - 100 Yes G2 ^)'
162
+ ( 2023-01-16 \(85\) 8:56 Week 12 Week 12 364 \(H\) U/L 0 - 100 Yes G3 *^#)'
163
+ ( 2023-04-04 \(163\) 9:42 Week 24 Week 24 78 U/L 0 - 100 Yes G0)'
164
+ ( 2023-06-27 \(247\) 8:30 Week 36 Week 36 74 U/L 0 - 100 Yes G0)'
165
+ ( )'
166
+ (Participant ID = 02106-10009 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 64/F/BL/NH)'
167
+ (First Dose = 2022-09-29 Last Dose \(Study Day\) = Ongoing)'
168
+ ( )'
169
+ (Urinalysis Urine Glucose 2022-09-14 \(-15\) 11:48 Screening Baseline Normal NA No G0)'
170
+ ( 2022-09-29 \(1\) 10:08 Day 1 Baseline Normal NA Yes G0)'
171
+ ( 2022-10-27 \(29\) 9:07 Week 4 Week 4 Normal NA Yes G0)'
172
+ ( 2022-12-19 \(82\) 11:24 Week 12 Week 12 Normal NA Yes G0)'
173
+ ( 2023-03-13 \(166\) 10:35 Week 24 Week 24 +3 \(H\) NA Yes G3 *^#)'
174
+ ( 2023-06-12 \(257\) 10:50 Week 36 Week 36 +4 \(H\) NA Yes G3 *^#)'
175
+ ( )'
176
+ (Participant ID = 02728-10065 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 58/M/AS/NH)'
177
+ (First Dose = 2022-11-18 Last Dose \(Study Day\) = Ongoing)'
178
+ ( )'
179
+ (______________________________________________________________________________________________________________________________________________________)'
180
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
181
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
182
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
183
+ (A treatment-emergent marked laboratory abnormality was defined as an increase of at least 3 toxicity grades from baseline at any postbaseline time)'
184
+ (point, up to and including the last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR group\).)'
185
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
186
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
187
+ ( )'
188
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
189
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-mark.pdf 12APR2024: 9:02 Page 3 of 5)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.1.7: Treatment-Emergent Marked Laboratory Abnormalities)'
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+ ( All Randomized Analysis Set)'
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+ ( )'
204
+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( )'
206
+ ( Toxi-)'
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+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
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+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
209
+ (______________________________________________________________________________________________________________________________________________________)'
210
+ ( )'
211
+ (Chemistry Serum Glucose \(Nonfasting\) 2023-05-04 \(168\) 10:00 Unscheduled Week 24 255 \(H\) mg/dL 70 - 100 No G3 *^#)'
212
+ ( )'
213
+ (Participant ID = 04170-10110 Treatment = SBR Age/Sex/Race/Ethnicity = 65/M/WH/NH)'
214
+ (First Dose = 2023-01-11 Last Dose \(Study Day\) = Ongoing)'
215
+ ( )'
216
+ (Chemistry Creatinine Clearance 2022-11-29 \(-43\) 10:40 Screening Baseline 87.6 mL/min 85 - 125 Yes G2)'
217
+ ( 2023-01-11 \(1\) 11:35 Day 1 Baseline 103.0 mL/min 85 - 125 Yes G0)'
218
+ ( 2023-02-09 \(30\) 10:10 Week 4 Week 4 80.6 \(L\) mL/min 85 - 125 Yes G2 ^)'
219
+ ( 2023-04-06 \(86\) 15:50 Week 12 Week 12 87.6 mL/min 85 - 125 Yes G2 ^)'
220
+ ( 2023-06-29 \(170\) 15:10 Week 24 Week 24 71.4 \(L\) mL/min 85 - 125 Yes G3 *^#)'
221
+ ( )'
222
+ (Participant ID = 25207-10043 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 72/M/WH/NP)'
223
+ (First Dose = 2022-11-03 Last Dose \(Study Day\) = Ongoing)'
224
+ ( )'
225
+ (Urinalysis Urine Glucose 2022-10-31 \(-3\) 11:00 Screening Baseline Trace \(H\) NA Yes G1)'
226
+ ( 2022-11-03 \(1\) 10:25 Day 1 Baseline Normal NA Yes G0)'
227
+ ( 2022-12-01 \(29\) 10:30 Week 4 Week 4 +4 \(H\) NA No G3 *^#)'
228
+ ( 2023-01-26 \(85\) 7:00 Week 12 Week 12 +4 \(H\) NA Yes G3 *^#)'
229
+ ( 2023-04-21 \(170\) 8:45 Week 24 Week 24 +4 \(H\) NA Yes G3 *^#)'
230
+ ( 2023-07-17 \(257\) 11:00 Week 36 Week 36 +4 \(H\) NA Yes G3 *^#)'
231
+ ( )'
232
+ (Participant ID = 25207-10105 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 62/M/WH/NH)'
233
+ (First Dose = 2023-01-09 Last Dose \(Study Day\) = 2023-05-02 \(114\))'
234
+ ( )'
235
+ (Urinalysis Urine Glucose 2022-12-08 \(-32\) 13:20 Screening Baseline +3 \(H\) NA Yes G3)'
236
+ (______________________________________________________________________________________________________________________________________________________)'
237
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
238
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
239
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
240
+ (A treatment-emergent marked laboratory abnormality was defined as an increase of at least 3 toxicity grades from baseline at any postbaseline time)'
241
+ (point, up to and including the last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR group\).)'
242
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
243
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
244
+ ( )'
245
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
246
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-mark.pdf 12APR2024: 9:02 Page 4 of 5)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Listing 16.2.8.1.7: Treatment-Emergent Marked Laboratory Abnormalities)'
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+ ( All Randomized Analysis Set)'
260
+ ( )'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( )'
263
+ ( Toxi-)'
264
+ (Lab Test Date of Collection Time Analysis Lab Normal Fasting city)'
265
+ (Type Name \(Study Day\) \(hh:mm\) Visit Visit Result Unit Range Status Flag)'
266
+ (______________________________________________________________________________________________________________________________________________________)'
267
+ ( )'
268
+ (Urinalysis Urine Glucose 2023-01-09 \(1\) 8:30 Day 1 Baseline Normal NA Yes G0)'
269
+ ( 2023-02-07 \(30\) 9:45 Week 4 Week 4 +3 \(H\) NA Yes G3 *^#)'
270
+ ( 2023-04-04 \(86\) 10:15 Week 12 Week 12 +2 \(H\) NA Yes G2 ^)'
271
+ ( 2023-05-04 \(116\) 9:15 ESDD Week 12 +4 \(H\) NA Yes G3 *^#)'
272
+ ( )'
273
+ (Participant ID = 25508-10083 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 53/F/WH/NH)'
274
+ (First Dose = 2022-12-14 Last Dose \(Study Day\) = Ongoing)'
275
+ ( )'
276
+ (Chemistry Serum Glucose \(Nonfasting\) 2023-01-11 \(29\) 10:31 Week 4 Week 4 275 \(H\) mg/dL 70 - 100 No G3 *^#)'
277
+ ( 2023-03-07 \(84\) 10:15 Week 12 Week 12 160 \(H\) mg/dL 70 - 100 No G1 ^)'
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+ ( )'
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+ ( )'
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+ ( )'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
295
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
296
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
297
+ (A treatment-emergent marked laboratory abnormality was defined as an increase of at least 3 toxicity grades from baseline at any postbaseline time)'
298
+ (point, up to and including the last dose date plus 60 days in BIC+LEN groups \(or plus 30 days in SBR group\).)'
299
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
300
+ (^=Treatment-emergent laboratory abnormality;#=Treatment-emergent marked laboratory abnormality;*=Maximum postbaseline toxicity grade for a given test.)'
301
+ ( )'
302
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
303
+ (Source: .../wk_24_p2/version2/prog/l-lbtox.sas v9.4 Output file: l-lbtox-mark.pdf 12APR2024: 9:02 Page 5 of 5)'
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+ ( Listing 16.2.8.1.8: Liver-Related Laboratory Tests)'
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+ ( Safety Analysis Set)'
31
+ ( )'
32
+ (______________________________________________________________________________________________________________________________________________________)'
33
+ ( )'
34
+ ( Total Direct Alkaline)'
35
+ (Date of ALT AST Bilirubin Bilirubin Phosphatase)'
36
+ (Collection Day Visit Analysis Visit \(U/L\) \(U/L\) \(mg/dL\) \(mg/dL\) \(U/L\))'
37
+ (______________________________________________________________________________________________________________________________________________________)'
38
+ ( )'
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+ (Participant ID = 00959-10079 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 64/M/WH/NH)'
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+ (First Dose = 2022-12-13 Last Dose \(Study Day\) = 2023-07-17 \(217\))'
41
+ ( )'
42
+ (2022-11-11 \( -32\) Screening Baseline 34 29 0.6 0.2 116)'
43
+ (2022-12-13 \( 1\) Day 1 Baseline 34 35 0.8 0.2 113)'
44
+ (2023-01-10 \( 29\) Week 4 Week 4 35 31 0.6 0.2 134 \(H\))'
45
+ (2023-03-13 \( 91\) Week 12 Week 12 37 32 1.2 0.2 132 \(H\))'
46
+ (2023-05-30 \( 169\) Week 24 Week 24 42 46 \(H\) 1.4 \(G1,H\)* 0.3 121)'
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+ ( )'
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+ (Participant ID = 00986-10125 Treatment = SBR Age/Sex/Race/Ethnicity = 57/F/BL/H)'
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+ (First Dose = 2023-01-24 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
51
+ (2022-12-13 \( -42\) Screening Baseline 21 21 3.7 \(G3,H\)^ 0.4 89)'
52
+ (2023-01-03 \( -21\) Unscheduled Baseline 15 18 2.7 \(G2,H\)^ 0.4 106 \(H\))'
53
+ (2023-01-24 \( 1\) Day 1 Baseline 21 24 2.7 \(G2,H\)^ 0.3 106 \(H\))'
54
+ (2023-02-21 \( 29\) Week 4 Week 4 19 20 3.7 \(G3,H\)^ 0.2 82)'
55
+ (2023-02-28 \( 36\) Unscheduled Week 4 20 22 2.8 \(G2,H\)^ 0.3 87)'
56
+ (2023-04-13 \( 80\) Week 12 Week 12 26 24 2.9 \(G2,H\)^ 0.2 69)'
57
+ (2023-07-06 \( 164\) Week 24 Week 24 20 20 3.3 \(G3,H\)^ 0.2 74)'
58
+ (2023-07-19 \( 177\) Unscheduled Week 24 19 22 1.9 \(G1,H\)* 0.4 68)'
59
+ ( )'
60
+ (Participant ID = 00986-10126 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 68/M/BL/NH)'
61
+ (First Dose = 2023-01-24 Last Dose \(Study Day\) = Ongoing)'
62
+ ( )'
63
+ (2022-12-13 \( -42\) Screening Baseline 24 25 0.5 0.1 94)'
64
+ (______________________________________________________________________________________________________________________________________________________)'
65
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
66
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
67
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
68
+ (Data from postbaseline visits up to last study drug dose plus 60 days in BIC+LEN groups \(last dose of SBR plus 30 days in SBR group\) were included.)'
69
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
70
+ (* means "> 3 x ULN" for ALT or AST, "> 1 x ULN" for Total Bilirubin \(TB\), and ">1.5 x ULN" for Alkaline Phosphatase \(ALP\).)'
71
+ (^ means "> 5 x ULN" for ALT or AST, "> 2 x ULN" for TB. # means "> 10 x ULN" for ALT or AST. & means "> 20 x ULN" for ALT or AST.)'
72
+ ( )'
73
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
74
+ (Source: .../wk_24_p2/version2/prog/l-lbliver.sas v9.4 Output file: l-lbliver.pdf 07DEC2023:11:20 Page 1 of 4)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
86
+ ( Listing 16.2.8.1.8: Liver-Related Laboratory Tests)'
87
+ ( Safety Analysis Set)'
88
+ ( )'
89
+ (______________________________________________________________________________________________________________________________________________________)'
90
+ ( )'
91
+ ( Total Direct Alkaline)'
92
+ (Date of ALT AST Bilirubin Bilirubin Phosphatase)'
93
+ (Collection Day Visit Analysis Visit \(U/L\) \(U/L\) \(mg/dL\) \(mg/dL\) \(U/L\))'
94
+ (______________________________________________________________________________________________________________________________________________________)'
95
+ ( )'
96
+ (2023-01-24 \( 1\) Day 1 Baseline 17 28 0.7 0.2 79)'
97
+ (2023-02-21 \( 29\) Week 4 Week 4 18 22 0.3 0.1 95)'
98
+ (2023-04-13 \( 80\) Week 12 Week 12 18 22 0.6 0.2 83)'
99
+ (2023-07-06 \( 164\) Week 24 Week 24 20 27 1.3 \(H\)* 0.3 91)'
100
+ ( )'
101
+ (Participant ID = 01624-10077 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 70/M/BL/NH)'
102
+ (First Dose = 2022-12-08 Last Dose \(Study Day\) = Ongoing)'
103
+ ( )'
104
+ (2022-11-17 \( -21\) Screening Baseline 15 18 0.4 <0.1 59)'
105
+ (2022-12-08 \( 1\) Day 1 Baseline 13 19 0.7 0.2 54)'
106
+ (2023-01-05 \( 29\) Week 4 Week 4 16 19 0.9 0.2 54)'
107
+ (2023-02-28 \( 83\) Week 12 Week 12 24 28 0.8 0.2 53)'
108
+ (2023-05-23 \( 167\) Week 24 Week 24 19 26 1.7 \(G1,H\)* 0.4 63)'
109
+ (2023-08-15 \( 251\) Week 36 Week 36 16 25 0.8 0.2 57)'
110
+ ( )'
111
+ (Participant ID = 02854-10058 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 62/M/OT/NP)'
112
+ (First Dose = 2022-11-16 Last Dose \(Study Day\) = Ongoing)'
113
+ ( )'
114
+ (2022-10-20 \( -27\) Screening Baseline 15 17 1.1 0.2 45)'
115
+ (2022-11-16 \( 1\) Day 1 Baseline 10 14 0.6 0.2 46)'
116
+ (2022-12-14 \( 29\) Week 4 Week 4 28 26 1.2 0.2 58)'
117
+ (2023-02-02 \( 79\) Week 12 Week 12 28 23 0.8 0.2 61)'
118
+ (2023-05-02 \( 168\) Week 24 Week 24 19 20 1.5 \(G1,H\)* 0.3 58)'
119
+ (2023-07-20 \( 247\) Week 36 Week 36 26 27 2.1 \(G2,H\)* 0.4 72)'
120
+ ( )'
121
+ (______________________________________________________________________________________________________________________________________________________)'
122
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
123
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
124
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
125
+ (Data from postbaseline visits up to last study drug dose plus 60 days in BIC+LEN groups \(last dose of SBR plus 30 days in SBR group\) were included.)'
126
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
127
+ (* means "> 3 x ULN" for ALT or AST, "> 1 x ULN" for Total Bilirubin \(TB\), and ">1.5 x ULN" for Alkaline Phosphatase \(ALP\).)'
128
+ (^ means "> 5 x ULN" for ALT or AST, "> 2 x ULN" for TB. # means "> 10 x ULN" for ALT or AST. & means "> 20 x ULN" for ALT or AST.)'
129
+ ( )'
130
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
131
+ (Source: .../wk_24_p2/version2/prog/l-lbliver.sas v9.4 Output file: l-lbliver.pdf 07DEC2023:11:20 Page 2 of 4)'
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+ ( Listing 16.2.8.1.8: Liver-Related Laboratory Tests)'
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+ ( Safety Analysis Set)'
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+ ( )'
146
+ (______________________________________________________________________________________________________________________________________________________)'
147
+ ( )'
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+ ( Total Direct Alkaline)'
149
+ (Date of ALT AST Bilirubin Bilirubin Phosphatase)'
150
+ (Collection Day Visit Analysis Visit \(U/L\) \(U/L\) \(mg/dL\) \(mg/dL\) \(U/L\))'
151
+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( )'
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+ (Participant ID = 14678-10095 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 69/M/WH/NH)'
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+ (First Dose = 2022-12-20 Last Dose \(Study Day\) = Ongoing)'
155
+ ( )'
156
+ (2022-12-08 \( -12\) Screening Baseline 16 19 0.9 0.2 69)'
157
+ (2022-12-20 \( 1\) Day 1 Baseline 14 19 0.8 0.3 62)'
158
+ (2023-01-17 \( 29\) Week 4 Week 4 60 \(G1,H\) 35 1.4 \(G1,H\)* 0.4 69)'
159
+ (2023-03-14 \( 85\) Week 12 Week 12 47 43 \(H\) 1.3 \(G1,H\)* 0.3 66)'
160
+ (2023-06-07 \( 170\) Week 24 Week 24 35 29 1.0 0.2 59)'
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+ ( )'
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+ (Participant ID = 25207-10043 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 72/M/WH/NP)'
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+ (First Dose = 2022-11-03 Last Dose \(Study Day\) = Ongoing)'
164
+ ( )'
165
+ (2022-10-31 \( -3\) Screening Baseline 17 15 0.3 0.1 181 \(G1,H\))'
166
+ (2022-11-03 \( 1\) Day 1 Baseline 17 22 0.3 0.1 162 \(G1,H\))'
167
+ (2022-12-01 \( 29\) Week 4 Week 4 19 24 0.4 0.1 199 \(G1,H\)*)'
168
+ (2022-12-06 \( 34\) Unscheduled Week 4 19 20 0.4 0.2 207 \(G1,H\)*)'
169
+ (2023-01-26 \( 85\) Week 12 Week 12 14 18 0.4 0.1 151 \(H\))'
170
+ (2023-04-21 \( 170\) Week 24 Week 24 0.6 126)'
171
+ (2023-04-25 \( 174\) Unscheduled Week 24 21 22 0.4 0.1 123)'
172
+ (2023-07-17 \( 257\) Week 36 Week 36 21 26 0.4 0.1 132 \(H\))'
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+ ( )'
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+ (Participant ID = 25207-10055 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 73/M/WH/NH)'
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+ (First Dose = 2022-11-14 Last Dose \(Study Day\) = Ongoing)'
176
+ ( )'
177
+ (2022-10-18 \( -27\) Screening Baseline 23 24 0.4 0.1 77)'
178
+ (______________________________________________________________________________________________________________________________________________________)'
179
+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
180
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
181
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
182
+ (Data from postbaseline visits up to last study drug dose plus 60 days in BIC+LEN groups \(last dose of SBR plus 30 days in SBR group\) were included.)'
183
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
184
+ (* means "> 3 x ULN" for ALT or AST, "> 1 x ULN" for Total Bilirubin \(TB\), and ">1.5 x ULN" for Alkaline Phosphatase \(ALP\).)'
185
+ (^ means "> 5 x ULN" for ALT or AST, "> 2 x ULN" for TB. # means "> 10 x ULN" for ALT or AST. & means "> 20 x ULN" for ALT or AST.)'
186
+ ( )'
187
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
188
+ (Source: .../wk_24_p2/version2/prog/l-lbliver.sas v9.4 Output file: l-lbliver.pdf 07DEC2023:11:20 Page 3 of 4)'
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+ ( Listing 16.2.8.1.8: Liver-Related Laboratory Tests)'
201
+ ( Safety Analysis Set)'
202
+ ( )'
203
+ (______________________________________________________________________________________________________________________________________________________)'
204
+ ( )'
205
+ ( Total Direct Alkaline)'
206
+ (Date of ALT AST Bilirubin Bilirubin Phosphatase)'
207
+ (Collection Day Visit Analysis Visit \(U/L\) \(U/L\) \(mg/dL\) \(mg/dL\) \(U/L\))'
208
+ (______________________________________________________________________________________________________________________________________________________)'
209
+ ( )'
210
+ (2022-11-14 \( 1\) Day 1 Baseline 21 26 0.4 0.1 81)'
211
+ (2022-12-07 \( 24\) Week 4 Week 4 28 34 0.6 0.1 82)'
212
+ (2023-02-01 \( 80\) Week 12 Week 12 27 0.9)'
213
+ (2023-02-09 \( 88\) Unscheduled Week 12 27 26 1.0 0.2 78)'
214
+ (2023-05-02 \( 170\) Week 24 Week 24 20 22 0.8 0.2 73)'
215
+ (2023-07-25 \( 254\) Week 36 Week 36 27 28 1.6 \(G1,H\)* 0.3 79)'
216
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+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
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+ ( )'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ (AS = Asian; BL = Black; F = Female; M = Male; NA = Not Available; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; SBR = stable baseline)'
237
+ (regimen; WH = White. GX = Grade X; H = high; L = low. Severity grades were defined by the Division of AIDS \(DAIDS\) Toxicity Grading Scale, Version)'
238
+ (2.1. Day was the number of study days relative to the date of study Day 1. $ Imputed last dose date when completely or partially missing.)'
239
+ (Data from postbaseline visits up to last study drug dose plus 60 days in BIC+LEN groups \(last dose of SBR plus 30 days in SBR group\) were included.)'
240
+ (The "Toxicity Flag" includes the toxicity grade and the abnormal characterization, denoted by the following symbols:)'
241
+ (* means "> 3 x ULN" for ALT or AST, "> 1 x ULN" for Total Bilirubin \(TB\), and ">1.5 x ULN" for Alkaline Phosphatase \(ALP\).)'
242
+ (^ means "> 5 x ULN" for ALT or AST, "> 2 x ULN" for TB. # means "> 10 x ULN" for ALT or AST. & means "> 20 x ULN" for ALT or AST.)'
243
+ ( )'
244
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
245
+ (Source: .../wk_24_p2/version2/prog/l-lbliver.sas v9.4 Output file: l-lbliver.pdf 07DEC2023:11:20 Page 4 of 4)'
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Labs/Listing 16.2.8.1.9.pdf ADDED
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.1.9: Reference Ranges for Laboratory Tests)'
34
+ ( )'
35
+ ( ___________________________________________________________________________________________________________________________________________)'
36
+ ( Age Value)'
37
+ ( ______________________ ______________________)'
38
+ ( Lab Category Lab Test Sex Low High Unit Low High)'
39
+ ( ___________________________________________________________________________________________________________________________________________)'
40
+ ( )'
41
+ ( BLOOD CELLMARK CD4 Female 26 64 /uL 441 2156)'
42
+ ( 26 64 % 28.2 62.8)'
43
+ ( 65 74 % 19.8 64.3)'
44
+ ( Male 21 64 /uL 441 2156)'
45
+ ( 21 64 % 28.2 62.8)'
46
+ ( 65 80 % 19.8 64.3)'
47
+ ( )'
48
+ ( SERUM CHEMISTRY Alanine Aminotransferase Female 26 74 U/L 4 43)'
49
+ ( Male 21 80 U/L 5 48)'
50
+ ( )'
51
+ ( Albumin Female 26 68 g/dL 3.3 4.9)'
52
+ ( 69 74 g/dL 3.3 4.6)'
53
+ ( Male 21 68 g/dL 3.3 4.9)'
54
+ ( 69 79 g/dL 3.3 4.6)'
55
+ ( 80 80 g/dL 3 4.6)'
56
+ ( )'
57
+ ( Alkaline Phosphatase Female 26 74 U/L 35 104)'
58
+ ( Male 21 80 U/L 40 129)'
59
+ ( )'
60
+ ( Amylase Female 26 47 U/L 28 100)'
61
+ ( 52 58 U/L 28 120)'
62
+ ( 60 69 U/L 28 150)'
63
+ ( 70 74 U/L 50 252)'
64
+ ( Male 21 49 U/L 28 100)'
65
+ ( 50 59 U/L 28 120)'
66
+ ( 60 69 U/L 28 150)'
67
+ ( 70 80 U/L 50 252)'
68
+ ( )'
69
+ ( Aspartate Aminotransferase Female 26 74 U/L 8 40)'
70
+ ( Male 21 80 U/L 8 40)'
71
+ ( )'
72
+ ( Bicarbonate Female 26 74 mEq/L 19.3 29.3)'
73
+ ( Male 21 80 mEq/L 19.3 29.3)'
74
+ ( )'
75
+ ( Bilirubin Female 26 74 mg/dL 0.2 1.2)'
76
+ (______________________________________________________________________________________________________________________________________________________)'
77
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
78
+ (Source: .../wk_24_p2/version2/prog/l-s-lbrange.sas v9.4 Output file: l-s-lbrange.pdf 07DEC2023:11:21 Page 1 of 8)'
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+ ( Listing 16.2.8.1.9: Reference Ranges for Laboratory Tests)'
91
+ ( )'
92
+ ( ___________________________________________________________________________________________________________________________________________)'
93
+ ( Age Value)'
94
+ ( ______________________ ______________________)'
95
+ ( Lab Category Lab Test Sex Low High Unit Low High)'
96
+ ( ___________________________________________________________________________________________________________________________________________)'
97
+ ( )'
98
+ ( SERUM CHEMISTRY Bilirubin Male 21 80 mg/dL 0.2 1.2)'
99
+ ( )'
100
+ ( Calcium Female 26 74 mg/dL 8.3 10.6)'
101
+ ( Male 21 80 mg/dL 8.3 10.6)'
102
+ ( )'
103
+ ( Calcium Corrected for Albumin Female 26 74 mg/dL 8.3 10.6)'
104
+ ( Male 21 80 mg/dL 8.3 10.6)'
105
+ ( )'
106
+ ( Chloride Female 26 74 mEq/L 94 112)'
107
+ ( Male 21 80 mEq/L 94 112)'
108
+ ( )'
109
+ ( Cholesterol Female 26 27 mg/dL 128 218)'
110
+ ( 36 37 mg/dL 141 240)'
111
+ ( 40 47 mg/dL 155 265)'
112
+ ( 52 58 mg/dL 171 291)'
113
+ ( 60 69 mg/dL 188 320)'
114
+ ( 70 74 mg/dL 207 352)'
115
+ ( Male 35 38 mg/dL 150 264)'
116
+ ( 40 49 mg/dL 162 280)'
117
+ ( 50 59 mg/dL 170 291)'
118
+ ( 60 69 mg/dL 175 298)'
119
+ ( 70 80 mg/dL 177 300)'
120
+ ( )'
121
+ ( Creatine Kinase Female 26 74 U/L 26 192)'
122
+ ( Male 21 80 U/L 39 308)'
123
+ ( )'
124
+ ( Creatinine Female 26 57 mg/dL 0.35 1.14)'
125
+ ( 57 57 mg/dL 0.59 1.04)'
126
+ ( 58 58 mg/dL 0.35 1.14)'
127
+ ( 58 58 mg/dL 0.59 1.04)'
128
+ ( 60 69 mg/dL 0.35 1.14)'
129
+ ( 70 74 mg/dL 0.35 1.24)'
130
+ ( Male 21 49 mg/dL 0.45 1.24)'
131
+ ( 50 51 mg/dL 0.45 1.35)'
132
+ ( 51 51 mg/dL 0.74 1.35)'
133
+ (______________________________________________________________________________________________________________________________________________________)'
134
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
135
+ (Source: .../wk_24_p2/version2/prog/l-s-lbrange.sas v9.4 Output file: l-s-lbrange.pdf 07DEC2023:11:21 Page 2 of 8)'
136
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+ ( Listing 16.2.8.1.9: Reference Ranges for Laboratory Tests)'
148
+ ( )'
149
+ ( ___________________________________________________________________________________________________________________________________________)'
150
+ ( Age Value)'
151
+ ( ______________________ ______________________)'
152
+ ( Lab Category Lab Test Sex Low High Unit Low High)'
153
+ ( ___________________________________________________________________________________________________________________________________________)'
154
+ ( )'
155
+ ( SERUM CHEMISTRY Creatinine Male 52 69 mg/dL 0.45 1.35)'
156
+ ( 70 79 mg/dL 0.45 1.55)'
157
+ ( 80 80 mg/dL 0.45 1.64)'
158
+ ( )'
159
+ ( Creatinine Clearance Female 26 74 mL/min 75 115)'
160
+ ( Male 21 80 mL/min 85 125)'
161
+ ( )'
162
+ ( Direct Bilirubin Female 26 74 mg/dL 0.4)'
163
+ ( Male 21 80 mg/dL 0.4)'
164
+ ( )'
165
+ ( Fasting Cholesterol Female 26 27 mg/dL 128 218)'
166
+ ( 36 37 mg/dL 141 240)'
167
+ ( 40 47 mg/dL 155 265)'
168
+ ( 52 58 mg/dL 171 291)'
169
+ ( 60 69 mg/dL 188 320)'
170
+ ( 70 74 mg/dL 207 352)'
171
+ ( Male 35 38 mg/dL 150 264)'
172
+ ( 40 49 mg/dL 162 280)'
173
+ ( 50 59 mg/dL 170 291)'
174
+ ( 60 69 mg/dL 175 298)'
175
+ ( 70 80 mg/dL 177 300)'
176
+ ( )'
177
+ ( Fasting Glucose Female 26 74 mg/dL 70 100)'
178
+ ( Male 21 80 mg/dL 70 100)'
179
+ ( )'
180
+ ( Fasting HDL Cholesterol Female 26 74 mg/dL 40 60)'
181
+ ( Male 35 80 mg/dL 40 60)'
182
+ ( )'
183
+ ( Fasting Triglycerides Female 26 27 mg/dL 36 144)'
184
+ ( 36 37 mg/dL 39 176)'
185
+ ( 40 47 mg/dL 45 214)'
186
+ ( 52 58 mg/dL 52 262)'
187
+ ( 60 74 mg/dL 56 240)'
188
+ ( Male 35 38 mg/dL 50 321)'
189
+ ( 40 49 mg/dL 55 327)'
190
+ (______________________________________________________________________________________________________________________________________________________)'
191
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
192
+ (Source: .../wk_24_p2/version2/prog/l-s-lbrange.sas v9.4 Output file: l-s-lbrange.pdf 07DEC2023:11:21 Page 3 of 8)'
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204
+ ( Listing 16.2.8.1.9: Reference Ranges for Laboratory Tests)'
205
+ ( )'
206
+ ( ___________________________________________________________________________________________________________________________________________)'
207
+ ( Age Value)'
208
+ ( ______________________ ______________________)'
209
+ ( Lab Category Lab Test Sex Low High Unit Low High)'
210
+ ( ___________________________________________________________________________________________________________________________________________)'
211
+ ( )'
212
+ ( SERUM CHEMISTRY Fasting Triglycerides Male 50 59 mg/dL 58 320)'
213
+ ( 60 80 mg/dL 58 260)'
214
+ ( )'
215
+ ( Follicle Stimulating Hormone Male 56 60 mIU/mL 1.3 19.3)'
216
+ ( )'
217
+ ( Glucose Female 26 74 mg/dL 70 100)'
218
+ ( Male 21 80 mg/dL 70 100)'
219
+ ( )'
220
+ ( HDL Cholesterol Female 26 74 mg/dL 40 60)'
221
+ ( Male 35 80 mg/dL 40 60)'
222
+ ( )'
223
+ ( Indirect Bilirubin Female 26 74 mg/dL 0 1.2)'
224
+ ( Male 21 80 mg/dL 0 1.2)'
225
+ ( )'
226
+ ( Lactate Dehydrogenase Female 26 74 U/L 53 234)'
227
+ ( Male 21 80 U/L 53 234)'
228
+ ( )'
229
+ ( Lipase Female 26 58 U/L 0 100)'
230
+ ( 60 69 U/L 0 120)'
231
+ ( 70 74 U/L 0 130)'
232
+ ( Male 21 59 U/L 0 100)'
233
+ ( 60 69 U/L 0 120)'
234
+ ( 70 80 U/L 0 130)'
235
+ ( )'
236
+ ( Magnesium Female 26 58 mg/dL 1.6 2.6)'
237
+ ( 60 74 mg/dL 1.6 2.4)'
238
+ ( Male 21 59 mg/dL 1.6 2.6)'
239
+ ( 60 80 mg/dL 1.6 2.4)'
240
+ ( )'
241
+ ( Nonfasting Glucose Female 26 74 mg/dL 70 100)'
242
+ ( Male 29 79 mg/dL 70 100)'
243
+ ( )'
244
+ ( Phosphate Female 26 74 mg/dL 2.2 5.1)'
245
+ ( Male 21 80 mg/dL 2.2 5.1)'
246
+ ( )'
247
+ (______________________________________________________________________________________________________________________________________________________)'
248
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
249
+ (Source: .../wk_24_p2/version2/prog/l-s-lbrange.sas v9.4 Output file: l-s-lbrange.pdf 07DEC2023:11:21 Page 4 of 8)'
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+ ( Gilead Sciences, Inc.)'
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261
+ ( Listing 16.2.8.1.9: Reference Ranges for Laboratory Tests)'
262
+ ( )'
263
+ ( ___________________________________________________________________________________________________________________________________________)'
264
+ ( Age Value)'
265
+ ( ______________________ ______________________)'
266
+ ( Lab Category Lab Test Sex Low High Unit Low High)'
267
+ ( ___________________________________________________________________________________________________________________________________________)'
268
+ ( )'
269
+ ( SERUM CHEMISTRY Potassium Female 26 74 mEq/L 3.5 5.2)'
270
+ ( Male 21 80 mEq/L 3.5 5.2)'
271
+ ( )'
272
+ ( Protein Female 26 58 g/dL 6.1 8.4)'
273
+ ( 60 74 g/dL 6 8)'
274
+ ( Male 21 58 g/dL 6.1 8.4)'
275
+ ( 59 80 g/dL 6 8)'
276
+ ( )'
277
+ ( Sodium Female 26 58 mEq/L 132 147)'
278
+ ( 60 74 mEq/L 135 145)'
279
+ ( Male 21 58 mEq/L 132 147)'
280
+ ( 59 80 mEq/L 135 145)'
281
+ ( )'
282
+ ( Triglycerides Female 26 27 mg/dL 36 144)'
283
+ ( 36 37 mg/dL 39 176)'
284
+ ( 40 47 mg/dL 45 214)'
285
+ ( 52 58 mg/dL 52 262)'
286
+ ( 60 74 mg/dL 56 240)'
287
+ ( Male 35 38 mg/dL 50 321)'
288
+ ( 40 49 mg/dL 55 327)'
289
+ ( 50 59 mg/dL 58 320)'
290
+ ( 60 80 mg/dL 58 260)'
291
+ ( )'
292
+ ( Urate Female 26 47 mg/dL 2.1 7.2)'
293
+ ( 52 74 mg/dL 2.5 7.5)'
294
+ ( Male 21 49 mg/dL 2.1 8.2)'
295
+ ( 50 80 mg/dL 2.5 8.3)'
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+ ( Urea Nitrogen Female 26 69 mg/dL 4 24)'
298
+ ( 70 74 mg/dL 4 29)'
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+ ( Male 21 69 mg/dL 4 24)'
300
+ ( 70 79 mg/dL 4 29)'
301
+ ( 80 80 mg/dL 4 34)'
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+ ( )'
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+ ( BLOOD HEMATOLOGY Basophils Female 26 74 x10^3/uL 0 0.2)'
304
+ (______________________________________________________________________________________________________________________________________________________)'
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+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
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+ ( ___________________________________________________________________________________________________________________________________________)'
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+ ( Age Value)'
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+ ( ______________________ ______________________)'
323
+ ( Lab Category Lab Test Sex Low High Unit Low High)'
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+ ( ___________________________________________________________________________________________________________________________________________)'
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+ ( BLOOD HEMATOLOGY Basophils Male 21 80 x10^3/uL 0 0.2)'
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+ ( Basophils/Leukocytes Female 26 74 % 0 2)'
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+ ( Male 21 80 x10^3/uL 0 0.57)'
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+ ( Eosinophils/Leukocytes Female 26 74 % 0 6.8)'
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+ ( 59 80 fL 80 100)'
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+ ( 59 80 % 37 51)'
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+ ( 60 74 g/dL 11.5 15.8)'
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+ ( Male 21 58 g/dL 12.7 18.1)'
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+ ( 59 80 g/dL 12.5 17)'
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+ ( Leukocytes Female 26 74 x10^3/uL 3.8 10.7)'
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+ ( Male 21 80 x10^3/uL 3.8 10.7)'
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+ ( Lymphocytes Female 26 58 x10^3/uL 0.91 4.28)'
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+ ( 60 74 x10^3/uL 0.8 3)'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
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+ ( ___________________________________________________________________________________________________________________________________________)'
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+ ( Age Value)'
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+ ( Lab Category Lab Test Sex Low High Unit Low High)'
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+ ( ___________________________________________________________________________________________________________________________________________)'
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+ ( BLOOD HEMATOLOGY Lymphocytes Male 21 58 x10^3/uL 0.91 4.28)'
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+ ( 59 80 x10^3/uL 0.8 3)'
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+ ( Lymphocytes/Leukocytes Female 26 74 % 15.4 48.5)'
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+ ( Neutrophils Band Form Male 35 35 x10^3/uL 0 0.27)'
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+ ( )'
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+ ( Neutrophils Band Form/Leukocytes Male 35 35 % 0 3)'
398
+ ( )'
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+ ( Neutrophils, Segmented Female 26 74 x10^3/uL 1.96 7.23)'
400
+ ( Male 21 80 x10^3/uL 1.96 7.23)'
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+ ( )'
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+ ( Neutrophils/Leukocytes Female 26 74 % 40.5 75)'
403
+ ( Male 21 80 % 40.5 75)'
404
+ ( )'
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+ ( Platelets Female 26 58 x10^3/uL 140 400)'
406
+ ( 60 74 x10^3/uL 130 394)'
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+ ( Male 21 59 x10^3/uL 140 400)'
408
+ ( 60 80 x10^3/uL 130 394)'
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+ ( Reticulocytes/Erythrocytes Female 26 74 % 0.6 2.5)'
411
+ ( Male 21 80 % 0.6 2.5)'
412
+ ( )'
413
+ ( SERUM IMMUNOLOGY Thyrotropin Female 26 74 uIU/mL 0.45 5.33)'
414
+ ( Male 21 80 uIU/mL 0.45 5.33)'
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+ ( )'
416
+ ( URINE URINALYSIS Specific Gravity Female 26 58 1.003 1.035)'
417
+ ( 60 74 1.006 1.03)'
418
+ (______________________________________________________________________________________________________________________________________________________)'
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+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
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+ ( ___________________________________________________________________________________________________________________________________________)'
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+ ( Age Value)'
436
+ ( ______________________ ______________________)'
437
+ ( Lab Category Lab Test Sex Low High Unit Low High)'
438
+ ( ___________________________________________________________________________________________________________________________________________)'
439
+ ( )'
440
+ ( URINE URINALYSIS Specific Gravity Male 21 58 1.003 1.035)'
441
+ ( 59 80 1.006 1.03)'
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+ ( Squamous Epithelial Cells Female 47 69 /HPF 0 3)'
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+ ( Male 21 80 /HPF 0 3)'
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+ ( Urine Leukocytes Female 26 74 /HPF 0 12)'
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+ ( Male 21 80 /HPF 0 5)'
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+ ( pH Female 26 74 5 8)'
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+ ( Male 21 80 5 8)'
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+ ( )'
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+ ( )'
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+ ( )'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
477
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( )'
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+ ( )'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ ( )'
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+ ( No Pregnancy was Reported During the Study.)'
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+ ( )'
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+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.5.1: Substance Use)'
29
+ ( All Randomized Analysis Set)'
30
+ ( )'
31
+ (______________________________________________________________________________________________________________________________________________________)'
32
+ ( )'
33
+ (Substance Category Type of Substance Start Date \(Study Day\) Stop Date \(Study Day\))'
34
+ (______________________________________________________________________________________________________________________________________________________)'
35
+ ( )'
36
+ (Participant ID = 00777-10099 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 63/M/WH/NH)'
37
+ (First Dose = 2023-01-03 Last Dose \(Study Day\) = Ongoing)'
38
+ ( )'
39
+ (RECREATIONAL DRUGS Methamphetamine 1988 1993)'
40
+ (RECREATIONAL DRUGS Marijuana 2007 Ongoing)'
41
+ ( )'
42
+ (Participant ID = 00986-10126 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 68/M/BL/NH)'
43
+ (First Dose = 2023-01-24 Last Dose \(Study Day\) = Ongoing)'
44
+ ( )'
45
+ (RECREATIONAL DRUGS Marijuana 1973 Ongoing)'
46
+ ( )'
47
+ (Participant ID = 00991-10032 Treatment = SBR Age/Sex/Race/Ethnicity = 54/M/WH/NH)'
48
+ (First Dose = 2022-10-26 Last Dose \(Study Day\) = Ongoing)'
49
+ ( )'
50
+ (OTHER: TOBACCO Other: NICOTINE 1985 2022-04)'
51
+ (OTHER: VAPING Other: VAPING 2022-04 Ongoing)'
52
+ ( )'
53
+ (Participant ID = 02058-10026 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 39/F/BL/NH)'
54
+ (First Dose = 2022-10-20 Last Dose \(Study Day\) = Ongoing)'
55
+ ( )'
56
+ (RECREATIONAL DRUGS Marijuana 2001 Ongoing)'
57
+ ( )'
58
+ (Participant ID = 02058-10029 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 59/M/WH/NH)'
59
+ (First Dose = 2022-10-24 Last Dose \(Study Day\) = Ongoing)'
60
+ ( )'
61
+ (RECREATIONAL DRUGS Marijuana 2015 Ongoing)'
62
+ ( )'
63
+ (Participant ID = 02106-10009 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 64/F/BL/NH)'
64
+ (First Dose = 2022-09-29 Last Dose \(Study Day\) = Ongoing)'
65
+ ( )'
66
+ (RECREATIONAL DRUGS Cocaine 2000)'
67
+ (______________________________________________________________________________________________________________________________________________________)'
68
+ (AS = Asian; BL = Black; F = Female; M = Male; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; WH = White.)'
69
+ (D = Day; SBR = stable baseline regimen; Y = Year.)'
70
+ (Day was the number of study days relative to the date of study Day 1.)'
71
+ ( )'
72
+ (Data Extracted: CRF Data: 22AUG2023, Lab Data: 22AUG2023, PK Data: 22AUG2023)'
73
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+ ( )'
88
+ (______________________________________________________________________________________________________________________________________________________)'
89
+ ( )'
90
+ (Substance Category Type of Substance Start Date \(Study Day\) Stop Date \(Study Day\))'
91
+ (______________________________________________________________________________________________________________________________________________________)'
92
+ ( )'
93
+ (Participant ID = 02854-10059 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 65/M/WH/NH)'
94
+ (First Dose = 2022-11-16 Last Dose \(Study Day\) = Ongoing)'
95
+ ( )'
96
+ (RECREATIONAL DRUGS Marijuana 1997-01-01 \(-26 Y\) Ongoing)'
97
+ (RECREATIONAL DRUGS Methamphetamine 2005-01-01 \(-18 Y\) 2022-04-01 \(-229 D\))'
98
+ ( )'
99
+ (Participant ID = 02854-10078 Treatment = SBR Age/Sex/Race/Ethnicity = 64/M/WH/NH)'
100
+ (First Dose = 2022-12-12 Last Dose \(Study Day\) = Ongoing)'
101
+ ( )'
102
+ (RECREATIONAL DRUGS Marijuana 1975 Ongoing)'
103
+ ( )'
104
+ (Participant ID = 02854-10084 Treatment = SBR Age/Sex/Race/Ethnicity = 59/M/WH/NH)'
105
+ (First Dose = 2022-12-14 Last Dose \(Study Day\) = Ongoing)'
106
+ ( )'
107
+ (RECREATIONAL DRUGS Marijuana 2000-01-01 \(-23 Y\) Ongoing)'
108
+ ( )'
109
+ (Participant ID = 05171-10027 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 58/M/WH/NH)'
110
+ (First Dose = 2022-10-24 Last Dose \(Study Day\) = Ongoing)'
111
+ ( )'
112
+ (RECREATIONAL DRUGS Marijuana 1981 Ongoing)'
113
+ ( )'
114
+ (Participant ID = 05171-10067 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 47/M/WH/NH)'
115
+ (First Dose = 2022-11-22 Last Dose \(Study Day\) = Ongoing)'
116
+ ( )'
117
+ (RECREATIONAL DRUGS Marijuana Ongoing)'
118
+ ( )'
119
+ (Participant ID = 08083-10114 Treatment = BIC 75 mg plus LEN 25 mg Age/Sex/Race/Ethnicity = 59/M/WH/NH)'
120
+ (First Dose = 2023-01-17 Last Dose \(Study Day\) = Ongoing)'
121
+ ( )'
122
+ (RECREATIONAL DRUGS Marijuana 2016-04-27 \(-7 Y\) Ongoing)'
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+ (AS = Asian; BL = Black; F = Female; M = Male; \(N\)H = \(Not\) Hispanic; NP = Not Permitted; OT = Other; WH = White.)'
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+ (D = Day; SBR = stable baseline regimen; Y = Year.)'
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+ ( Gilead Sciences, Inc.)'
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+ ( Study GS-US-621-6289 \(Phase 2 Week 24 Analysis\))'
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+ ( Listing 16.2.8.5.1: Substance Use)'
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+ ( All Randomized Analysis Set)'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ (Substance Category Type of Substance Start Date \(Study Day\) Stop Date \(Study Day\))'
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+ (______________________________________________________________________________________________________________________________________________________)'
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+ (Participant ID = 15110-10028 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 37/M/BL/NH)'
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+ (First Dose = 2022-10-24 Last Dose \(Study Day\) = Ongoing)'
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+ ( )'
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+ (RECREATIONAL DRUGS Marijuana 2004 Ongoing)'
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+ (Participant ID = 25508-10092 Treatment = BIC 75 mg plus LEN 50 mg Age/Sex/Race/Ethnicity = 66/M/BL/NH)'
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+ (First Dose = 2022-12-20 Last Dose \(Study Day\) = 2023-06-09 \(172\)$)'
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+ ( )'
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+ (RECREATIONAL DRUGS Marijuana 1986 Ongoing)'
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+ (D = Day; SBR = stable baseline regimen; Y = Year.)'
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