title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Results | PMC10025222 | |||
RFS for nivolumab versus placebo and nivolumab versus ipilimumab | death, melanoma | RECURRENCE, MELANOMA | In the pooled population, patients in the nivolumab arm showed an improvement in RFS compared with those in the placebo arm (HR for recurrence or death: 0.49; 95% CI 0.39–0.61) and ipilimumab arm (HR for recurrence or death: 0.69; 95% CI 0.56–0.85; Fig. Weighted RFS in the pooled study population by treatment arm. Shad... | PMC10025222 |
OS for nivolumab versus placebo | The estimated post-recurrence survival was higher in CheckMate 238 than in EORTC 18,071 by 3.0% at 12 months, 3.7% by 24 months, 7.3% by 36 months, and 9.1% at 48 months. OS outcomes for nivolumab, placebo, and the placebo arm after adjustment are displayed in Fig. OS for nivolumab and placebo after adjusting for diffe... | PMC10025222 | ||
Discussion | resected stage IIIB-C, resected melanoma, melanoma | RECURRENCE, MELANOMA, DISEASE, CUTANEOUS MELANOMA, MELANOMA STAGING | This post hoc ITC, which used pooled, long-term follow-up data from the phase 3 EORTC 18,071 and CheckMate 238 trials [Despite emerging evidence for the benefits of novel adjuvant melanoma treatments, the historical standard approach of surveillance alone may be an option in certain clinical situations and used in real... | PMC10025222 |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 188 KB) | PMC10025222 | ||
Acknowledgements | Medical writing support was provided by Loraine Georgy, PhD, an employee of Analysis Group, Inc., which received consultancy fees from Bristol Myers Squibb for conducting research analysis. Editorial support for the development of this manuscript, under the direction of the authors, was provided by Mark Palangio and Mi... | PMC10025222 | ||
Author contributions | TP, EXD, YW, KAB, and ANS conceived or designed the study. EXD, TW, YC, YW, and KAB were involved in data acquisition. TP, BDS, LAS, EXD, TW, YC, YW, and KAB were involved in data analysis. JSW, TP, BDS, LAS, EXD, KAB, and ANS were involved in data interpretation. All authors approved the final version of the manuscrip... | PMC10025222 | ||
Funding | Cancer | CANCER | This study was supported by Bristol Myers Squibb (Princeton, NJ) and a National Cancer Institute (NCI) Cancer Center Core Grant (P30CA008748) to ANS. | PMC10025222 |
Data availability | The Bristol Myers Squibb policy on data sharing may be found at | PMC10025222 | ||
Declarations | PMC10025222 | |||
Conflict of interest | Cancer | CANCER | JSW reports stock ownership in Biond, CytoMx, Evaxion, NexImmune, and Protean; receiving consulting or advisory fees from AstraZeneca, Biond, Bristol Myers Squibb (BMS), Celldex, CytomX, Evaxion, GlaxoSmithKline (GSK), Genentech, Idera, Incyte, Merck, NexImmune, Novartis, OncoSec, Pfizer, Ultimovacs, Regeneron, and Sel... | PMC10025222 |
Ethical approval | All study participants provided informed consent and both trials were approved by their respective Institutional Review Boards and were conducted under the Declaration of Helsinki. | PMC10025222 | ||
References | PMC10025222 | |||
1. Introduction | PMC10664897 | |||
1.1 Background of the study | Agricultural sectors were the leading sector in Ethiopian economy, 47.7% of the total GDP compared to 13.3% for industry and 39% for services [The growing method and specific agronomic practices can considerably improve the quality and biological value of pepper fruits [Most of the farmers in central rift valley includ... | PMC10664897 | ||
2. Materials and methods | PMC10664897 | |||
2.1 Description of the study area | Alage ATVET College is embraced in the central Rift Valley basins which have a semi-arid agro- climatic zone [ | PMC10664897 | ||
2.2 Climatic characteristics and soil type | The average annual rainfall is 800 mm. Now a day, the area is experiencing recurrent drought. The annual mean minimum and maximum temperatures were 11 and 29°C [ | PMC10664897 | ||
Long-term rainfall and ET | PMC10664897 | |||
2.3 Experimental field layout and water application | The experimental site was laid out in a randomized complete block design (RCBD) in a factorial arrangement replicated three times per treatment were shown in ( | PMC10664897 | ||
Layout of experimental field. | PMC10664897 | |||
Treatments setting for the experiment detail layout of the field. | Note: Water applied to crop was by three-meter length in-line drip with 0.394 lit./hr. discharge and 90.26% emission uniformity. Using paired container (Barrel) with 400 litter volume sets the middle of plot. The main pipe was a high-density pipe (HDP) and ran for 23.6 m length and 25 mm internal diameter for each repl... | PMC10664897 | ||
2.4 Mareko fana water requirement estimation and transplanting | INFILTRATION | Reference evapotranspiration was estimated by the Penman-Monteith method by using cropwat 8.0. The input dates were location (70 36’ 00’’N latitude and 380 24’ 55’’E longitudes and altitude of 1600 m), climatic data (sunshine, wind speed, relative humidity, temperature and rainfall), crop type and soil data (OMC, infil... | PMC10664897 | |
2.5 Soil sampling and analysis | Nine representative soil samples before planting were randomly collected at 0–20, 20–40 and 40–60 cm each depth in a diagonal walk from the experimental field using an auger to have three composite samples. The soil sample was air dried on plastic trays, ground and sieved to pass through 2 mm sieve. Since 90% of pepper... | PMC10664897 | ||
2.6 Hydraulic characteristics of drip irrigation system | Drip emitters flow in the experiment was measured and checked by taking water samples from three levels of water at the tanker (full, half and minimum level) and averaging it. Three catch cans were randomly assigned each plot was placed beneath drip emitters by excavated the soil. Water dropout from each emitter was co... | PMC10664897 | ||
Recommended classifications of emission uniformity. | Source: Gireesh [ | PMC10664897 | ||
2.7 Data collection and analysis | ET deficit | Phenology and growth parameters: Plant phenological parameters such as days to 50% flowering and 50% maturity were recorded on a plot basis from the two central rows. Plant height, number of primary branches per plant, number of leaves per plant, number of flowers per plant, stem diameter, number of pods per plant, pod... | PMC10664897 | |
3. Results and discussion | INFILTRATION, INFILTRATION | Infiltration rate and cumulative infiltration of the experimental site were 5.1 and 22.46 cm/hr. respectively. The basic infiltration rate of sandy loam soil is within the range of 1.3 to 7.6 cm/hr. [ | PMC10664897 | |
Soil physico-chemical properties of the experimental site. | PMC10664897 | |||
3.1 Monthly reference evapotranspiration (ETO) | The long term as well as in the research time reference evapo transpiration (ET | PMC10664897 | ||
Long term and research time monthly reference evapotranspiration of the research area. | The long-term ETOn the above ( | PMC10664897 | ||
Applied net irrigation water depth at different deficit levels for mareko fana pepper. | The result specifies that the maximum amount of water was applied around the end of February up to the second week of March. This matches with the stage of fruit formation (3 | PMC10664897 | ||
Depth of water applied for each stage of mareko fana pepper. | PMC10664897 | |||
3.2.1 Plant height | Pepper height showed a highly significant (P<0.01) among the different irrigation levels was presented in ( | PMC10664897 | ||
The effect of irrigation levels on height of mareko fana pepper. | The effect of irrigation levels on plant height treated with 0% DI had the tallest plant height (50.47cm) and was significantly different from all deficit irrigations. The shortest plant height (30.67 cm) was recorded from DI of 60% DI application and was significantly inferior to all irrigation levels. This decrease i... | PMC10664897 | ||
3.2.2 Leaf number per plant | Leaf numbers per plant was significantly (P<0.01) affected by irrigation levels. The effects of deficit irrigation levels insignificant effect on a number of leaves per plant at 0, 10, 20 and 30% DI but the difference started from 40% deficit levels ( | PMC10664897 | ||
Analysis of variance of selected agronomic and phonological related parameters. | Where: -This result was similar to Yemane | PMC10664897 | ||
3.2.3 Stem diameter | The obtained result showed that the stem diameter was significantly (P<0.01) influenced by irrigation levels. Stem diameter at 0, 10, 20 and 30% deficit levels show an insignificant difference but a significant difference was observed after 40% DI level (P<0.01). Comparing with effects of different irrigation levels, t... | PMC10664897 | ||
Effect of irrigation levels on stem diameter. | PMC10664897 | |||
3.2.4 Number of primary branches per plant | The analysis of variance on effects of irrigation levels for number of primary branches per plant is presented in ( | PMC10664897 | ||
Effect of irrigation levels on branch number. | Number of primary branches per plant varied from 5.8 to 10.9 under irrigation deficit levels between 60 and 0% DI. This difference was observed when irrigation levels increased the plant generate more branches and leaf resulted a large pod size. This finding was confirmed by Adel | PMC10664897 | ||
3.2.5 Number of flowers per plant | The effect of deficit irrigation on number of flowers showed highly significant (P<0.01) in this study showed in ( | PMC10664897 | ||
The effect of irrigation levels on number of flowers per plant. | Accordingly, the highest number of flowers per plant was recorded from 20% deficit level was 96.07 with the same significant levels of 10% DI. The least number of flowers per plant was also observed from 40% ETC level got 33.17 due to water stress to make ready nutrients for the plant. Variations of flowers caused by t... | PMC10664897 | ||
3.2.6 Days to 50% flowering | The number of days to 50% flowering revealed a significant (P<0.01) difference in response to the effects of deficit irrigation levels ( | PMC10664897 | ||
3.2.7 Days to 50% maturity | Number of days to 50% maturity was a highly significant difference in response to the effect of deficit irrigation levels (P< 0.01). 0% and 10 and 20% deficit had insignificant differences on 50% maturity days as shown below in | PMC10664897 | ||
The effect of irrigation levels on 50% maturity date. | Treatment that received 0% DI irrigation required 134.7 days with the same significant level of 10% deficit (ANOVA analysis showed that water levels received an insignificant difference between 50 and 60% irrigation levels. Thus, plants grown with soil moisture deficit levels on average days took 12.84, 6.83, 5.79, 3.6... | PMC10664897 | ||
3.3 Yield and yield components | PMC10664897 | |||
3.3.1 Number of pod per plant | Analysis of variance from ANOVA table for total number of fruits per plant revealed that significant effect (P<0.01) between 60, 50 and 20% DI due to effect of deficit irrigation levels shown in | PMC10664897 | ||
The effect of irrigation levels on number of pods per plant. | Maximum number of fruits per plant (85.4) was recorded from 20% deficit irrigation level while minimum fruit number per plant (20.93) was observed from 60% DL which was four times lower than 80% ETC. Insignificant difference between plots that received 30, 20, 10 and 0% DI while significant difference with other levels... | PMC10664897 | ||
3.3.2 Pod length | Analysis of variance showed, there was insignificant difference (P<0.01) effect on mean fruit length at 0% and 10, 20 and 30% DI and also 50 and 60% DI due to effect of deficit irrigation levels.The longest fruits (11.53 cm) were obtained from plots received 0% DI while treatment received 60% DI (5.51cm) gave the short... | PMC10664897 | ||
The Effect of irrigation levels on pod length. | PMC10664897 | |||
Analysis of variance on yield component plant of mareko fana pepper. | Where: NPP- number of pods per plant, PL- Pod length, PDF -diameter of the fruit, FWPP- fruits weight per plant. CV-coefficient of variation and s.e -standard error. | PMC10664897 | ||
3.3.3 Diameter of fruit | Fruit diameter was measured to grade marketable pepper produced. The analysis of variance for fruit diameter has shown a highly significant (P<0.01) difference among irrigation levels. The largest fruit diameter (2.14 cm) was obtained from the plots that received full ETC, while the treatment that received 60% DI (1.23... | PMC10664897 | ||
Effect of irrigation levels on fruit diameter. | These finding shows, a large fruit diameter obtained from full irrigation was agreed with Yemane | PMC10664897 | ||
3.3.4 Fruits weight per plant | Analysis of variance showed that attainments to fruit weight per plant of mareko fana pepper highly significant (P<0.01) difference were presented in ( | PMC10664897 | ||
Effect of irrigation levels on total fruit weight per plant. | The highest fruit weight per plant of 745.8 gm was observed from full ETC and the lowest with106.5g in 60% deficit level with a trivial difference with 50% DI. However, Fruit weight per plant showed there had a high significant difference in response to deficit irrigation application between each irrigation level. The ... | PMC10664897 | ||
3.3.5 Marketable yield | Analysis of variance on marketable yield showed that the effect of deficit irrigation levels performs a highly significant difference (P< 0.01) in all deficit levels on marketable yield ( | PMC10664897 | ||
The effect of irrigation levels on marketable yield per hectare. | The above result showed for each irrigation level, marketable yield decreased with increased in deficit levels. The trend implies marketable yield was lower as the soil moisture stress increase. This finding clearly shows that increased photosynthetic area in response to moisture availability significantly contributed ... | PMC10664897 | ||
3.3.6 Unmarketable yield | The analysis of variance showed that the effect of deficit irrigation levels resulted a significant difference (P<0.01) effect on unmarketable yield. Unmarketable dry yield shows significant difference at 0, 40 and 60% deficit but insignificant difference in other deficit levels (P<0.01) as shown in the above ( | PMC10664897 | ||
The effect of irrigation levels on unmarketable dry yield. | PMC10664897 | |||
Effect of deficit irrigation levels on fresh and dry marketable, unmarketable and total yield of hot pepper at Alage in 2019/20 dry cropping season. | Where: FMY-fresh marketable yield, FUMY-fresh unmarketable yield, FTY-fresh total yield, DM-dry marketable yield, DNMY-dry unmarketable yield, (q/ha) and DTY-dry total yield CV-coefficient of variation and s.e-standard error.The result revealed that, when deficit levels increased the small size, shirked, yellowish and ... | PMC10664897 | ||
3.3.7 Total yield | The sum of unmarketable and marketable pepper yields gives the total pepper yield. Total yield was highly influenced by deficit irrigation levels as shown in ( | PMC10664897 | ||
Effect of irrigation levels on total yield per hectare. | Maximum fresh and dry total yield (13.80 and 6.4 t/ha) from 0% deficit followed by crops that received 10% deficit levels (11.1 and 5.90 t/ha) respectively. Whereas, the minimum total fresh and dry yields (5.16 and 2.27 t/ha) were got from 60% deficit level. Total fruit yield was decreased by increasing deficit irrigat... | PMC10664897 | ||
3.4 Drip irrigation water use efficiency | PMC10664897 | |||
3.4.1 Yield and water relationship | The highest total yield of Mareko fana hot pepper 6.54 t/ha was obtained from 100% ETC. The treatment received 60% deficit levels throughout the growing season was produced 2.27 t/ha by saving 66.6% of water was the smallest total yield produced. The result exhibited that the highest yield reduction (65.32%) was observ... | PMC10664897 | ||
Yield, water saved and relative yield reduction relationship under different deficit irrigation levels at Alage Central rift valley of Ethiopia. | Where: MY- marketable yield, NMY- unmarketable yield and TY- total yield.This consistent decrease in yield with decreased water amount under different deficit levels is explained by the fact that when full crop water requirement was not met, water deficit in the plant causes stomata closure for the plant to save water,... | PMC10664897 | ||
3.4.2 Crop Water Use Efficiency (CWUE) | The CWUE in the study measures the effectiveness of the irrigation levels and drip irrigation methods in converting the total water applied to Mareko fana hot pepper yield. CWUE of Mareko fana hot pepper was (P< 0.05) affected by the effects of deficit irrigation levels as shown in ( | PMC10664897 | ||
The effect of deficit irrigation levels on crop and irrigation water uses efficiencies of Mareko fana hot pepper at Alage in 2019/2020 dry season. | The highest crop water use efficiencies (14.22 kg/m3) were obtained from 60% deficit level, whereas the lowest crop water use efficiency (10.40 kg/m3) was obtained from full irrigation water levels. These results show a positive effect on irrigation deficit levels. CWUE was increased within the same water application m... | PMC10664897 | ||
3.4.3 Irrigation Water Use Efficiency (IWUE) | Irrigation water use efficiency is considered as relative pepper yield per unit of irrigation water used. IWUE revealed significant differences at 0, 20 and 60% Dl (P< 0.01) but insignificant difference on other levels (The finding was confirmed by Arebu | PMC10664897 | ||
3.4.4 Yield response factors (Ky) | Yield response factor (Ky) was derived from the relationship of relative yield reduction and evapotranspiration deficits for the whole growing period of hot pepper were given in | PMC10664897 | ||
The yield response factor values for irrigation treatments. | The crop yield response factor (Ky) captures the essence of the complex linkages between production and water use by a crop. Crop yield response factor indicates a linear relationship between the decrease in relative water consumption and the decrease in relative yield. Larger yield reductions when deficit increased be... | PMC10664897 | ||
3.5 Summary and conclusion | The results of this experiment showed that the water requirement of mareko fana pepper was low at initial stage, and it gradually increased in crop development stages, attaining a peak in the fruit establishing stage of pepper. Almost all parameters except flower and pod number per plant were recorded maximum under dri... | PMC10664897 | ||
3.6. Recommendation | DEFICIT | Based on the study and the results obtained on yield, yield components, and water productivity of pepper, the following important recommendations were made:❖ To achieve maximum mareko fana pepper yield in areas where water was not scarce, applying full irrigation throughout the whole growing season under in line drip i... | PMC10664897 | |
Subject terms | fatigue, CML-CP, diarrhea, chronic myeloid leukemia, Anderson Symptom Inventory – CML, ’ CML | CHRONIC MYELOID LEUKEMIA, CML | In ASCEMBL, an open-label, randomized Phase 3 study, asciminib demonstrated superior efficacy and better safety profile compared with bosutinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) previously treated with ≥2 tyrosine kinase inhibitors. Health-related quality of life (HRQOL) reported by pa... | PMC10169655 |
Introduction | CML-CP, leukemia, CML, ’ | LEUKEMIA, CML, CHRONIC MYELOID LEUKEMIA | Chronic myeloid leukemia (CML) accounts for ~15% of all new cases of leukemia [Each TKI has a specific safety profile with associated side effects that can ultimately affect adherence to therapy and health-related quality of life (HRQOL). Hence, patient-reported outcomes (PROs) are critical in precisely reporting and e... | PMC10169655 |
Materials and methods | PMC10169655 | |||
Study design | ASCEMBL is a phase 3, multi-center, open-label, randomized clinical trial (Fig. | PMC10169655 | ||
Schematic of Study Design. | CML-CP | CHRONIC MYELOID LEUKEMIA | ATP: adenosine triphosphate, BID: twice daily, CML-CP: chronic myeloid leukemia in chronic phase, QD: once daily, TKI: tyrosine kinase inhibitor Switch to asciminib allowed for bosutinib-treated patients meeting the lack of efficacy criteria based on the 2013 European LeukemiaNet recommendations for second-line TKI the... | PMC10169655 |
Frequency of PRO assessments | Anderson Symptom Inventory – CML | CML | Four self-reported PRO questionnaires (M.D. Anderson Symptom Inventory – CML [MDASI-CML], five-level EQ-5D [EQ-5D-5L], Patient Global Impression of Change – CML [PGIC-CML], and Work Productivity and Activity Impairment – CML [WPAI-CML]), each assessing different aspects of patients’ HRQOL and experience on treatment, w... | PMC10169655 |
PRO questionnaires | PMC10169655 | |||
MDASI-CML: CML symptoms and interference with daily life | rash/skin, cancers, nausea, fatigue, diarrhea, swelling, numbness, vomiting, pain, headache, dry mouth, shortness of breath | CML, CANCERS, DRY MOUTH, LACK OF APPETITE | The MDASI-CML is a validated 26-item, multi-symptom PRO questionnaire for clinical and research use. The MDASI-CML includes 13 core symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types (assessing pain, fatigue, nausea, disturbed sleep, feeling distressed, sho... | PMC10169655 |
EQ-5D-5L: patients’ general HRQOL | The EQ-5D-5L is a standardized measure of health utility providing a single index value for one’s health status and is used for economic evaluations of healthcare. The EQ-5D-5L is composed of a descriptive system of five dimensions and a visual analogue scale (VAS). The VAS component is a measure of self-rated health, ... | PMC10169655 | ||
PGIC-CML: patients’ impression of change in CML symptoms | CML | CHRONIC MYELOID LEUKEMIA, CML | The PGIC-CML is a single-item scale that asks: “Since the start of the treatment you’ve received in this study, your Chronic Myeloid Leukemia (CML) symptoms are…” with seven response options: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, and (7) v... | PMC10169655 |
WPAI-CML: impact on work and activity | CML | The WPAI-CML is a six-item PRO questionnaire that assesses the effect of CML on patients’ ability to work and perform regular activities (recalling the previous 7 days). In patients that report that they are working, three scales are calculated: work time missed (absenteeism), impairment while working (presenteeism), a... | PMC10169655 | |
Interpretation of PRO scores—Meaningful changes | For consistency across the PRO questionnaires, and due to the lack of published data relating to minimally important difference (MID) thresholds for the CML-specific instruments (MDASI-CML and WPAI-CML), a threshold of 1.5 points or 15% is used in this analysis as a guide to clinically meaningful thresholds, in line wi... | PMC10169655 | ||
Statistical analysis methods | The completion rate of each PRO questionnaire was summarized as a percentage out of the number of randomized patients who were expected at that visit; patients expected at each post-baseline visit were those who remained on randomized treatment and had not progressed, switched treatment, died, or withdrawn from the stu... | PMC10169655 | ||
Results | PMC10169655 | |||
Patient characteristics | Of the 233 randomized patients in ASCEMBL, 157 were randomized to receive asciminib and 76 to bosutinib. Overall, the median age at baseline was 52 years (range 19–83) and approximately half ( | PMC10169655 | ||
Patients’ symptoms and HRQOL at start of study | CML, Fatigue | CML | The mean MDASI-CML symptom severity score at baseline was 2.0 points, indicating that overall symptoms reported by patients before the start of treatment were of a relatively low severity. Fatigue was the most severe symptom reported at baseline with a mean score of 3.9 points. Patients reported that CML interfered wit... | PMC10169655 |
Change from baseline over time in PRO scores | PMC10169655 | |||
Change in symptom severity and symptom distress (MDASI-CML) | The change from baseline over time using each of the item, symptom severity, and symptom distress scores (assessed using the MDASI-CML questionnaire up to week 48) in each treatment arm and the difference between the treatment arms in the overall mean PRO scores (least squares [LS] mean) were analyzed.Figure | PMC10169655 | ||
Change from Baseline in MDASI-CML Symptom Severity Score (MMRM analysis). | nausea, diarrhea, fatigue, vomiting, dry mouth | DRY MOUTH | BSL = baseline, CI = confidence interval, LS mean=least squares mean, WK = week. Score ranges from 0 to 10, with a higher score indicating greater symptom severity/interference. Number of patients remaining on treatment at each timepoint shown for asciminib and bosutinib. Negative change shows improvement; positive cha... | PMC10169655 |
MDASI-CML symptom and interference items: the difference between treatment arms in change from baseline scores. | nausea, diarrhea, vomiting, pain, −1.7, dry mouth | DRY MOUTH, LACK OF APPETITE | CI = confidence interval, LS Mean=least squares mean. LS mean (95% CI) for difference in change from baseline scores between treatment arms. Dashed lines = clinically meaningful differences (green in favor of asciminib; blue in favor of bosutinib).The difference in change from baseline scores between treatments shows a... | PMC10169655 |
Change in general HRQOL and patients’ perception of change | CML | Overall HRQOL as assessed by the EQ-5D-5L VAS remained similar to baseline in both arms during treatment. As observed in the analysis of MDASI-CML symptom and interference scores, there was a trend of improvement from baseline in HRQOL reported in the asciminib arm (4.8 points on the 0–100 VAS [95% CI 2.4, 7.2]), altho... | PMC10169655 | |
Change in work productivity and activity impairment | Patients in the asciminib arm reported a reduction in their activity impairment (6.5% reduction in impairment, compared to a 1.0% reduction in patients in the bosutinib arm). The analysis of impairment at work was limited due to the low proportion of patients who reported they were currently working. Trends similar to ... | PMC10169655 | ||
Changes from baseline across subgroups | CML-CP | CML | Changes from baseline in CML symptoms, interference in life, and HRQOL observed across specific subgroups of patients (based on sex, race, age, reason for prior TKI discontinuation, and number of prior TKI lines of therapy) were largely consistent with the results observed for the overall population in ASCEMBL across a... | PMC10169655 |
Discussion | nausea, diarrhea, CML-CP, fatigue, cancer, CML, vomiting, Fatigue | ADVERSE EVENTS, CANCER, CML | PRO assessments were pre-specified exploratory endpoints in ASCEMBL and, as such, were not powered to demonstrate significance; therefore, interpreting changes in PRO scores over time as well as differences in mean scores between treatment arms requires consideration of clinically meaningful thresholds. The MDASI User ... | PMC10169655 |
Conclusion | CML | Patients with resistant/intolerant CML-CP treated with asciminib in ASCEMBL showed a trend for improvement in CML disease- and treatment-related symptoms and HRQOL compared with baseline and relative to bosutinib within the first 48 weeks of treatment. Asciminib-treated patients did not report worsening of treatment-re... | PMC10169655 | |
Supplementary information | The online version contains supplementary material available at 10.1038/s41375-023-01888-y. | PMC10169655 | ||
Acknowledgements | Christine Yip (Adelphi Values, Boston, MA, USA) and Xiaowu Sun (former employee of Adelphi Values, Boston, MA, USA) for analysis of patient-reported outcomes data.Aurore Yocolly and Regina Corbin (Novartis Services Inc, East Hanover, NJ, USA) for study oversight and interpretation of patient-reported outcomes data.Edit... | PMC10169655 |
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