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|---|---|---|---|---|---|---|---|
Common Errors
|
ClinicalTrials.gov “Basic Results” Database 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
DRAFT
|
60 60 • Report two different tables – Serious and Other – Do not report any serious adverse events in the Other Adverse
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Results Database
|
• Submitted data are used to develop basic tables for the public display • Tables must be interpretable by people not familiar with each particular study • Labels for rows, columns, and units of measure must be meaningful and precise 2 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Measure Type
|
• In general, spell out symbols such as – “Percentage” rather than “%” – “Number” rather than “No.” or “#” • Use decimal points (not commas) for the “decimal separator” and commas (not periods) for the “thousands separator” 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Participant Flow
|
• Number STARTED should be consistent with “Enrollment, Actual” in protocol section – Correct “Enrollment, Actual” (or explain inconsistencies in Pre- Assignment Details) • If more than one Period, number COMPLETED for each Period should equal number STARTED for next Period (or explain loss or addition of participants) • If “Milestones” are defined, number for each “Milestone”
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
must be
|
– Less than or equal to number STARTED Period (or number that achieved previous Milestone) – Greater than or equal to number COMPLETED Period (or number that achieved subsequent Milestone) 7 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
June 2006
|
Study Completion Date: October 2007 Primary Completion Date: October 2007 (Final data collection date for primary outcome measure) Basic Results Section: Summary Protocol Section:
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
NOT COMPLETED
|
0 0 0 0 Participant Flow: Overall Study EXAMPLE: Dose Escalation – Different Participants Receive Each Dose (Public View) Arms/Groups
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
level cohort
|
[1] [2] [3] [1] Dose level given only after lower dose was successfully administered [2] Dose level given only after lower dose was successfully administered [3] 2 participants were paired with each dose level of Drug X 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
STARTED
|
4 2 Low Dose (5 mg) 4 2 Medium Dose (50 mg) 4 2 High Dose (100 mg) 4 2
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Helpful Hints
|
• Measure Title • Specific name of scale • Spell out acronym, add acronym in parentheses • Measure Description • Construct/Domain if not clear from Measure Title • e.g., pain, quality of life • Range and direction of scores (e.g., 0 is best; 10 is worst) • Optional: Type of scale • e.g., continuous, ordinal • Unit of Measure • Use “participants,” if applicable (i.e., for categorical data) • Use “units on a scale” or “scores on a scale,” if no other units (i.e., for continuous data) 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
about these values
|
(e.g., is “0” better or worse than “2”?) Correct: Values within each scale category represent number of “participants”
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
BEFORE Revision
|
Brief description added to indicate “directionality”
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
AFTER Revision
|
BEFORE & AFTER Revision (Data Entry View)
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Walking
|
4 3 – Limited Self-Care, Partly Confined to Bed 0 4 – Completely Disabled, No
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Self-Care
|
0 AFTER Revision (Public View)
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Baseline Measures
|
Invalid Data in Total Column 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
possible results
|
• For categories based on continuous measures, provide thresholds when possible – Especially for 2 categories (i.e., dichotomous measures) 22 How to Define a Category:
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Drug X
|
Number of Participants 100 100 Number of participants improved on nausea scale [units: participants]
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Nausea
|
[units: Improved] 40 70 Need to explain the scale: • Range • Directionality “Improved” is not a
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
measurable unit
|
Report both possible outcomes as dichotomous categories: “improved” and “not improved” BEFORE Revision (Public View) 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
values represent
|
number of participants who “improved” Specified: • Range (1-10) • Directionality (1 = severe) • Algorithm (score at 8
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
score and defined
|
“improved” as greater than a 3-point difference) 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Measure Name
|
Assessment of Safety of 10 Dose Levels of Drug X Following 5 Cycles, Consisting of a 2- Week Exposure Period Followed by a 1-Week Rest Period, as Measured by Severe Toxicity and Disease Progression
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Measure Description
|
MTD, as measured by unacceptable toxicity, is exceeded if >33% participants experienced Dose Limiting Toxicities (DLT)
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Data
|
AFTER Revision (Public View) Outcome Measure Name and
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
No
|
Secondary Outcome Measure: Use of Community Health Resources
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
High Dose
|
Number of Participants Analyzed 35 34 Frequency and Magnitude of Antibody Response [units: participants] 17 21 May mean “three-fold or greater increase” BEFORE Revision (Public View)
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Updated Time Frame
|
31 31 Secondary Outcome Measure: Pain Assessment by Patient
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Time Frame
|
Any time during 5 cycles and 30 days
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Measured Values
|
BEFORE Revision (Public View) Reported Statistical Test not directly related to reported Outcome Measure Additional details about the analysis, such as null hypothesis and power calculation: [1] [2] [1] Effect onset is defined as half the time between initial assessment time indicating statistical significance and the previous assessment time. Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold of significance: [2] 2-sided statistical tests at 0.05 significance level [3] 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
needs to be numerical
|
(cannot include “+”) BEFORE Revision (Public View) 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
assessment
|
Population Description AFTER Revision (Public View) 36 of the 48 total participants had documented tumor progression by the 36-month assessment. Analysis Population Description describes results at 36 months Created categories for progression-free survival
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Placebo
|
Number of Participants Analyzed 125 120 Visual Analogue Scale (VAS) Pain Assessment at 1.5 Hours [units: scores on a scale] Least Squares Mean ± Standard Error 0.57 ± 0.08 1.12 ± 0.10 Statistical Analysis 1 for Visual Analogue Scale (VAS) Pain Score at 1.5 Hours 58
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Invalid entry
|
BEFORE Revision (Public View) 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Heart Rate at Rest
|
[units: beats per minute] Mean ± Standard Deviation 72.3 ± 2.7 71.9 ± 3.1 0 ± 0 BEFORE Revision (Public View)
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
provide values for
|
the “mean” and “standard deviation”
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
consistent
|
• Cells (data) represent measures or counts derived from participants within arms or groups – Measure Type (and Measure of Dispersion) needs to be consistent with data being reported – Unit of Measure must be consistent with values – Absolute values are preferable to percentages 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Week 10 to 18
|
Number of Participants Analyzed 88 80 Treatment Satisfaction Questionnaire After 18 Weeks of Treatment [units: scores on a scale] Mean ± Standard Deviation 81 ± 17.46 7.9 ± 12.16 Statistical Analysis 1 for Treatment Satisfaction Questionnaire After 18 Weeks Groups compared (“week 10” vs. “change from week 10 to 18”) not a logical t-test Confidence Interval is not meaningful without an Estimation Parameter (e.g., mean difference, hazard ratio) BEFORE Revision (Public View) 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Pharmacokinetics
|
[units: weeks] 6 BEFORE Revision (Public View) Not clear how to interpret this
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Outcome Measure table
|
• Time Frame: 6 Weeks • Units: Weeks • Outcome Data: 6
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Control
|
Number of Participants Analyzed 28 27 Hours Per Day of Sleep [units: average hours per day] Mean ± Standard Deviation 823 ± 92 864 ± 106 Inconsistency between Units of Measure, “average hours per day,” and Measure Data: value provided is greater than the total number of hours in a day BEFORE Revision (Public View) 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Inconsistent units
|
– should be “Percentage” 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Relapse Rate
|
[units: number of relapses] 86 91 BEFORE Revision (Public View) Incorrect Outcome Measure Title: Units and Measure Data provide values for “number of relapses,” not “rate” (or a quantity in relation to another unit, e.g., “relapses per unit time”) Alternatively, if Outcome Measure Title and Measure Data provide values for numbers of participants that “relapsed,” then the Units should be “participants” 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Information
|
• Outcome Measure Title, Description – Name and description of measure must be informative to people not familiar with study – If categorized, need description of categories – Use neutral words in Title (e.g., “treatment response” rather than “improvement” or “increased response”) • Units should directly reflect data in the table • Viewers of the table should be able to understand what the numbers represent 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Yes
|
Primary Outcome Measure: Maximum Tolerated Dose (MTD)
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Indicates measure is
|
“number of alerts” BEFORE Revision (Public View) 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Discharge
|
Number of Participants Analyzed 90 86 Use of Community Health Resources [units: participants] 4 9 Indicates 4 participants (of 90 or 4.4%) in the “Early Discharge” group used the specified level
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
health resources
|
used – how was it measured? 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
represent measures
|
of “frequency” and “magnitude” “Participants” is not a unit of measure for “frequency” or “magnitude” Best to provide both categories for a dichotomous measure: • < 3x increase • ≥3x increase Best to provide both categories for a dichotomous measure: • < 3x increase • ≥3x increase 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Level 5
|
Number of Participants Analyzed 9 4 9 9 9 Maximum Tolerated Dose (MTD) [units: participants]
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Experienced DLT
|
1 0 3 2 5 Dose Level MTD 0 0 9 0 9 BEFORE Revision (Public View) Mismatch among Measure Name, Description, and Data 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Overall Response Rate
|
0.21 95% Confidence Interval 0.12 to 0.33
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Unevaluable
|
6 Statistical Analysis 1 for Response to Drug X BEFORE Revision (Public View) Outcome Measure reported as categorical data (five categories of “response”) but Statistical Analysis provided as dichotomous data (“Overall Response Rate = Number Responded / Total Participants”) Need information on how the 5 categories were “collapsed” into 2 (i.e., Which of 5 response categories were used in calculating the “Overall Response Rate”?). 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Groups
|
Early Discharge vs. Standard Discharge
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
na
|
4.684 95% Confidence Interval 2.080 to 7.730
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
P-Value
|
0.05 Mean Difference (Net) 9 Statistical Analysis 1 for Parental Stress
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Standard Discharge
|
Number of Participants Analyzed 100 100
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Parental Stress
|
[units: points on a Likert scale] Mean ± Standard Deviation 9.3 ± 1.2 7.8 ± 2.1 Inconsistency between Measure Data and Method of Estimation • Reported Mean Difference: “9” • By Inspection: 9.3 – 7.8 = 1.5 BEFORE Revision (Public View) 1-09-09
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
Events table
|
– Note that a single type of Adverse Event Term (e.g., “asthma”) may appear in both the Serious and Other tables • If possible indicate the level of severity to distinguish “serious” from “other” adverse events (e.g., “asthma – mild and moderate” in the Other table; “asthma – severe” in the Serious table) • If no adverse events occurred, enter “0” for the Total Number Affected data elements – Do not enter 0 if you do not mean to imply that no adverse events
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
occurred
|
60 How to Report Adverse Events:
|
[
"FDAAA_CommonErrors.pdf"
] |
FDAAA_CommonErrors.pdf
|
pdf
|
glossary.json
| null | null |
DRAFT – Helpful Hints: Basic Results
|
9-28-09 ClinicalTrials.gov “Basic Results” Database
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Scales
|
Outcomes may be evaluated and reported with a specific scale. In order for the measure and the outcome to be easily understood, users should describe the scale in the Outcome Measure Title, Description, and Units of Measure fields (e.g., “Mean score on the National Library of Medicine (NLM) Pain Scale” Outcome Measure below). Specific items to describe include the following: Outcome Measure Title: Name of scale (e.g., mean score on NLM Pain Scale) Outcome Measure Description: o What the scale measures (e.g., severity of pain) o Range and direction (e.g., 0 is no pain and 20 is severe pain) o Other information as appropriate (e.g., whether the scale is ordinal or continuous). Units of Measure: expressed as “units on a scale,” “scores on a scale,” or “points on a scale” 3 DRAFT – Helpful Hints: Basic Results 9-28-09 4 3. STATISTICAL ANALYSES Statistical analyses are tied to a specific Outcome Measure. The system allows for the entry of p-values and/or confidence intervals. There is no limit to the number of analyses that can be entered for a given Outcome Measure (e.g., four statistical analyses are associated with the Primary Outcome Measure on pp. 7-9). If a p- value is entered, the test used must be specified. Similarly, if a confidence interval is entered, the estimated parameter must be specified. Users are encouraged to use the free text boxes to provide more complete explanations of their analyses. 4. ADVERSE EVENTS The Adverse Event module is optional (until Sept 27, 2009). However, if one chooses to use the module, the required data elements must be provided (e.g., pp. 10-11). There are separate tables for Serious Adverse Events, and for Other Adverse Events (based on frequency). The same event(s) involving the same participants should not be listed in both tables. DRAFT – Parallel Design Example – Public Display 9-28-09 Parallel Design Example This study has been completed. Information provided by Test Organization Study Type: Interventional Study Design: Randomized, Double Blind (Subject, Investigator, Outcomes Assessor),
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Parallel Assignment
|
Interventions: Drug: Drug A Drug: Drug B Drug: Placebo
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Recruitment Details
|
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
and January 2006
|
Pre-Assignment Details Significant events and approaches for the overall study following participant enrollment, but prior to group assignment Participants screened over 3 week period.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Description
|
Total Number of Participants All participants received the reference test (i.e. the gold standard). Serious Adverse Events Total Number of Participants Total # participants affected/at risk 0/2500
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
NOT COMPLETED
|
2 1 3 Lost to Follow-up 1 0 2
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Adverse Event
|
1 1 1 Baseline Characteristics
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Total
|
Number of Participants [units: participants] 50 50 50 150
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Age
|
[units: years] Mean ± Standard Deviation 57 ± 6
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
years
|
50 50 50 150 >=65 years 0 0 0 0
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Male
|
70 diastolic blood pressure [units: mm Hg] Mean ± Standard Deviation
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Outcome Measures
|
1. Primary Outcome Measure: Maximum Observed Plasma Concentration (Cmax)
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Measure Name
|
Plasma Decay Half-Life (t1/2) Measure Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Hide Details
|
Population Description Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. Each participant received reference and test drug and is, therefore, included in the analysis population for both the reference and test drug.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Placebo
|
Total # participants affected/at risk 16/50 4/50 13/50 Gastrointestinal disorders Nausea † # participants affected/at risk # events 4/50 (8%) 4 2/50 (4%) 2 2/50 (4%) 2 Nervous system disorders Headache † # participants affected/at risk
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
No
|
22 DRAFT – Diagnostic Test Accuracy Example – Public Display 9-28-09
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Time Frame
|
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Other Adverse Events
|
Frequency Threshold Above Which Other Adverse Events are Reported: 5% Total Number of Participants Total # participants affected/at risk 128/2500 Gastrointestinal disorders
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
number of events
|
12/50 (24%) 12 2/50 (4%) 2 11/50 (22%) 11 † Indicates events were collected by systematic assessment 10 DRAFT – Parallel Design Example – Public Display 9-28-09 11
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
More Information
|
Certain Agreements: Principal Investigators (PIs) are NOT employed by the organization sponsoring the study. There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI’s rights to discuss or publish trial results after the trial is completed. 28 DRAFT – Diagnostic Test Accuracy Example – Public Display 9-28-09 29 Limitations and Caveats Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data Only the most experienced technologists participated and were asked to read the test results in this study. Results may not be applicable to those centers without technologists with extensive related experience. Results Point of Contact: Name/Title: Dr. Y Organization: Test Coop phone: 123-457-9087 ext 1234 e-mail: abc@xyz.inc U.S. National Library of Medicine, Contact Help Desk U.S. National Institutes of Health, U.S. Department of Health & Human Services, USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act DRAFT – Bioequivalence Study Example – Public Display 9-28-09 Pharmacokinetic Outcome Measures (Bioequivalence Study) Example This study has been completed. Information provided by Test Organization
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
then Drug A
|
Placebo twice daily in first intervention period and Drug A 25 mg twice daily in second intervention period (after washout period). Drug A First,
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
then Placebo
|
Drug A 25 mg twice daily in first intervention period and Placebo twice daily in second intervention period (after washout period). 12 DRAFT – Crossover Study Example – Public Display 9-28-09 Participant Flow for 3 periods Period: First Intervention Placebo First,
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
STARTED
|
65 65 Received at Least One Dose of Drug 65 64
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Withdrawal by Subject
|
0 1 Period: Washout Period of 2 Weeks Placebo First,
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Disease relapse
|
2 1 Period: Second Intervention Placebo First,
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Lost to Follow-up
|
1 0 13 DRAFT – Crossover Study Example – Public Display 9-28-09 Baseline Characteristics
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Baseline Measures
|
Total Number of Participants Number of Participants [units: participants] 2600
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
At enrollment
|
138 ± 21.2 Beginning of Placebo treatment 138 ± 18.6 Beginning of Drug A treatment 136 ± 19.7
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
weight
|
[units: kg] Mean ± Standard Deviation 65 ± 11.2 [1] Measurements were taken at baseline, at beginning of 1st and 2nd intervention periods, and end of 1st and 2nd intervention periods. Yielding baseline measurements for treatment with Placebo and Drug A. 14 DRAFT – Crossover Study Example – Public Display 9-28-09
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Drug A
|
Total # participants affected/at risk 5/127 10/127 Gastrointestinal disorders Nausea ‡ # participants affected/at risk # events 5/127 (3.94%) 7 10/127 (7.87%) 12 ‡ Indicates events were collected by non-systematic methods. 19 DRAFT – Crossover Study Example – Public Display 9-28-09 20
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Two-sided
|
2. Primary Outcome Measure: Change from Baseline in Systolic Blood Pressure at 3
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
period and locations
|
2700 participants were selected from multiple primary care sites across the country and all were healthy at baseline without symptoms of disease. Pre-Assignment Details Significant events and approaches for the overall study following participant enrollment, but prior to group
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
assignment
|
100 participants were excluded because they did not properly observe the required pre-diagnostic test routine.
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Protocol Violation
|
100 21 DRAFT – Diagnostic Test Accuracy Example – Public Display 9-28-09 Baseline Characteristics
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Disease
|
Number of Participants Analyzed [units: Participants] 450 2050 Diagnostic Test Data for Disease Using Threshold B [units: participants] Positive diagnostic test for disease using threshold B 400 150 Negative diagnostic test for disease using threshold B 50 1900 Statistical Analysis 1 for Diagnostic Test Data for Disease Using Threshold B Groups [1] Participants With Disease Sensitivity [2] 0.89 95% Confidence Interval ( 0.84 to 0.95 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant estimation information: No text entered. Statistical Analysis 2 for Diagnostic Test Data for Disease Using Threshold B Groups [1] Participants Without Disease Specificity [2] 0.93 95% Confidence Interval ( 0.87 to 0.99 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant estimation information: No text entered. 25 DRAFT – Diagnostic Test Accuracy Example – Public Display 9-28-09 3. Primary Outcome Measure: Diagnostic Test Data for Disease Using Threshold C
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
Without Disease
|
Number of Participants Analyzed [units: Participants] 450 2050 Diagnostic Test Data for Disease Using Threshold C [units: participants] Positive diagnostic test for disease using threshold C 380 125 Negative diagnostic test for disease using threshold C 70 1925 26 DRAFT – Diagnostic Test Accuracy Example – Public Display 9-28-09 Statistical Analysis 1 for Diagnostic Test Data for Disease Using Threshold C Groups [1] Participants With Disease Sensitivity [2] 0.84 95% Confidence Interval ( 0.80 to 0.88 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant estimation information: No text entered. Statistical Analysis 2 for Diagnostic Test Data for Disease Using Threshold C Groups [1] Participants Without Disease Specificity [2] 0.94 95% Confidence Interval ( 0.89 to 0.99 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: No text entered. [2] Other relevant estimation information: No text entered. Statistical Analysis 3 for Diagnostic Test Data for Disease Using Threshold C Groups [1]
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
All groups
|
Area Under the Curve [2] 0.91 95% Confidence Interval ( 0.89 to 0.95 ) [1] Additional details about the analysis, such as null hypothesis and power calculation: The Area Under the Curve was estimated based on the sensitivity and specificity measures for each of three thresholds (A, B, and C) [2] Other relevant estimation information: No text entered. 27 DRAFT – Diagnostic Test Accuracy Example – Public Display 9-28-09 Reported Adverse Events
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
nausea
|
# participants affected/at risk # events 128/2500 (5.12%) 130
|
[
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] |
FDAAA_Helpful_Hints_ResultsExamples.pdf
|
pdf
|
glossary.json
| null | null |
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