Trial Outcomes & Findings for Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (NCT NCT05198934)
NCT ID: NCT05198934
Last Updated: 2026-07-22
Results Overview
PFS was defined as time from randomization until disease progression or death from any cause, whichever occurred first, for all participants. Progression was assessed using RECIST v1.1 per BICR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
160 participants
Primary outcome timeframe
From randomization until DCO or death; median (min, max) time on trial was 6.23 (0.1, 14.0) months
Results posted on
2026-07-22
Participant Flow
Participants were enrolled at 67 trial centers across Asia, Europe, North America, and Australia starting on 19 April 2022. The primary analysis results presented here, for primary analysis presented here are based on data cut-off (DCO) 19 June 2023. The trial is still ongoing.
Participants with previously treated metastatic colorectal cancer (CRC) with the kirsten rat sarcoma (KRAS) p.G12C mutation were enrolled and randomized 1:1:1 to receive either sotorasib 240 mg daily (QD) and panitumumab, sotorasib 960 mg QD and panitumumab, or investigator's choice (trifluridine and tipiracil, or regorafenib). Investigator's choice was declared prior to randomization.
Participant milestones
| Measure |
Trifluridine and Tipiracil or Regorafenib
Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 240 mg + Panitumumab
Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 960 mg + Panitumumab
Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
53
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
54
|
53
|
53
|
Reasons for withdrawal
| Measure |
Trifluridine and Tipiracil or Regorafenib
Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 240 mg + Panitumumab
Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 960 mg + Panitumumab
Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
|---|---|---|---|
|
Overall Study
Participants continuing trial
|
29
|
32
|
33
|
|
Overall Study
Withdrawal of consent from trial
|
5
|
2
|
2
|
|
Overall Study
Death
|
19
|
18
|
18
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
Baseline Characteristics
Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
Baseline characteristics by cohort
| Measure |
Trifluridine and Tipiracil or Regorafenib
n=54 Participants
Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 240 mg + Panitumumab
n=53 Participants
Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 960 mg + Panitumumab
n=53 Participants
Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 11.7 • n=9 Participants
|
58.2 years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
60.9 years
STANDARD_DEVIATION 11.6 • n=267 Participants
|
60.2 years
STANDARD_DEVIATION 11.7 • n=265 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
81 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=9 Participants
|
26 Participants
n=27 Participants
|
29 Participants
n=267 Participants
|
79 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
12 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=9 Participants
|
53 Participants
n=27 Participants
|
47 Participants
n=267 Participants
|
145 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
40 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
White
|
37 Participants
n=9 Participants
|
30 Participants
n=27 Participants
|
42 Participants
n=267 Participants
|
109 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
5 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: From randomization until DCO or death; median (min, max) time on trial was 6.23 (0.1, 14.0) monthsPopulation: FAS included all randomized participants.
PFS was defined as time from randomization until disease progression or death from any cause, whichever occurred first, for all participants. Progression was assessed using RECIST v1.1 per BICR.
Outcome measures
| Measure |
Trifluridine and Tipiracil or Regorafenib
n=54 Participants
Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 240 mg + Panitumumab
n=53 Participants
Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 960 mg + Panitumumab
n=53 Participants
Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
|---|---|---|---|
|
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by BICR
|
2.04 months
Interval 1.91 to 3.91
|
3.91 months
Interval 3.61 to 5.75
|
5.62 months
Interval 4.21 to 6.31
|
SECONDARY outcome
Timeframe: Approximately 3 yearsOS was defined as time from randomization until death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsObjective response was defined as best overall response (BOR) of complete response (CR) or partial response (PR), as defined by RECIST version 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. Responses were assessed based on BICR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsDOR was defined as time from first evidence of PR or CR until progressive disease (PD) or death due to any cause, whichever occurs first. CR was defined as disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsTTR was defined as time from randomization to the first evidence of PR or CR based on BICR. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsDCR was defined as the percentage of participants with the BOR of CR, PR or stable disease (SD) of at least 7 weeks based on BICR. CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on trial (this includes baseline sum if that is the smallest on trial).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsPFS by investigator assessment was defined as the time from randomization until PD or death due to any cause, whichever occurs first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsORR was defined as BOR of CR or PR, as defined by RECIST version 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. Responses were assessed based on investigator assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 3 yearsTEAEs were events with onset after the administration of the first dose of any trial treatment up to EOT or 30 days of the last dose of any trial treatment, or prior to first dose of crossed over treatment, whichever occurred earlier. Clinically significant changes in vital signs, and clinical laboratory tests were included as TEAEs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 8Item 3 of the BFI-SF recorded a participants' fatigue on a scale from 0 to 10. Higher scores indicated a higher severity of fatigue. An increase in score from baseline indicated a worsening of fatigue. A decrease in score from baseline indicated an improvement in fatigue.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 8Item 3 of the BPI-SF recorded a participants' pain on a scale from 1 to 10, where pain was mild (score of 1 to 4), moderate (score of 5 to 6), or severe (score of 7 to 10). An increase in score from baseline indicated a worsening of pain. A decrease in score from baseline indicates a lessening of pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 8The physical function domain of the EORTC QLQ-C30 assessed a participants' quality of life regarding their physical function on a scale from 1 to 4, with higher scores indicating a worse outcome. An increase in score from baseline indicated a worsening of physical functioning. A decrease in score from baseline indicated an improvement in physical functioning.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 8Questions 29 and 30 of the EORTC QLQ-C30 assessed a participants' global health status on a scale from 1 to 7, with higher scores indicating a better outcome. An increase in score from baseline indicated an improvement in global health status. A decrease in score from baseline indicated a worsening in global health status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 8The BFI-SF was a questionnaire that included 3 items to assess fatigue severity and 5 items to assess interference due to fatigue, with each item reported on a numeric rating scale from 0 to 10. Higher scores indicated a higher severity of fatigue. An increase in score from baseline indicated a worsening of fatigue. A decrease in score from baseline indicated an improvement in fatigue.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 8The BPI-SF was a 9-item questionnaire which included 2 body diagrams, four items to assess pain severity, four items to assess pain interference and one question about percentage of pain relief by analgesics. The level of pain and pain interference assessed could be divided into categories based on score of mild (1 to 4), moderate (5 to 6), and severe (7 to 10). An increase in score from baseline indicated a worsening of pain. A decrease in score from baseline indicated a lessening of pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 8The EORTC QLQ-C30 was a self-reporting 30-item generic instrument which assessed 5 functional domains (physical, role, emotional, cognitive, social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and a global health status/quality of life (QOL) scale. Higher scores indicated a worse outcome. An increase in score from baseline indicated a worsening of outcome. A decrease in score from baseline indicated an improvement in outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 8The EQ-5D-5L questionnaire was a 2-page, standardized instrument for use as a measure of health outcome. It was comprised of a 5-dimension health status measure and a visual analogue scale. The 5-dimension health status measure evaluates: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale recorded the participant's self-rated health on a vertical, visual analogue scale where the endpoints were labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsThe GP5 from the FACT-G was a single item included in the Physical Well-Being subscale of the FACT-G. Responses to the item: "I am bothered by side effects of treatment" are rated on a 5-point Likert scale from "not at all" to "very much".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsThe PGIC scale consisted of one item which measures the participants' perception of change in their condition relative to the beginning of the trial. Responses are rated on a 7-item response scale ranging from very much improved to very much worse.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsOutcome measures
Outcome data not reported
Adverse Events
Trifluridine and Tipiracil or Regorafenib
Serious events: 15 serious events
Other events: 48 other events
Deaths: 20 deaths
Sotorasib 240 mg + Panitumumab
Serious events: 17 serious events
Other events: 52 other events
Deaths: 18 deaths
Sotorasib 960 mg + Panitumumab
Serious events: 14 serious events
Other events: 52 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Trifluridine and Tipiracil or Regorafenib
n=51 participants at risk
Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 240 mg + Panitumumab
n=53 participants at risk
Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 960 mg + Panitumumab
n=53 participants at risk
Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
|---|---|---|---|
|
General disorders
Pain
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Cardiac disorders
Cardiac failure acute
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
General disorders
Pyrexia
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
General disorders
Condition aggravated
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
General disorders
General physical health deterioration
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Hepatobiliary disorders
Hepatic failure
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Klebsiella infection
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Pelvic abscess
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Sepsis
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Urosepsis
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to ovary
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.9%
2/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.9%
2/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Vascular disorders
Thrombosis
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
Other adverse events
| Measure |
Trifluridine and Tipiracil or Regorafenib
n=51 participants at risk
Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 240 mg + Panitumumab
n=53 participants at risk
Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
Sotorasib 960 mg + Panitumumab
n=53 participants at risk
Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.6%
11/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
15.1%
8/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
13.2%
7/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.8%
4/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
17/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.8%
4/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
4/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
13.2%
7/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
9.4%
5/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
3/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
7.5%
4/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Constipation
|
9.8%
5/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
11.3%
6/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
15.1%
8/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
12/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
26.4%
14/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
26.4%
14/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Nausea
|
35.3%
18/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
30.2%
16/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
15.1%
8/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Stomatitis
|
11.8%
6/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
7.5%
4/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
7.5%
4/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
6/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
20.8%
11/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
11.3%
6/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
General disorders
Asthenia
|
19.6%
10/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
17.0%
9/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
15.1%
8/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
General disorders
Fatigue
|
19.6%
10/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
9.4%
5/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
7.5%
4/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
General disorders
Malaise
|
5.9%
3/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
General disorders
Mucosal inflammation
|
5.9%
3/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
13.2%
7/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
General disorders
Oedema peripheral
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
General disorders
Pyrexia
|
15.7%
8/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
7.5%
4/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
General disorders
Xerosis
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
7.5%
4/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
COVID-19
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Conjunctivitis
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
7.5%
4/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Folliculitis
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
15.1%
8/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Paronychia
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
11.3%
6/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
9.4%
5/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Infections and infestations
Urinary tract infection
|
3.9%
2/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
11.3%
6/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Investigations
Blood alkaline phosphatase increased
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Investigations
Neutrophil count decreased
|
7.8%
4/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
7.5%
4/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Investigations
Weight decreased
|
7.8%
4/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
9.4%
5/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
6/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
9.4%
5/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
3/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
3/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
9.4%
5/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
34.0%
18/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
34.0%
18/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
2/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
15.1%
8/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
5/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
9.4%
5/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Nervous system disorders
Headache
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
11.3%
6/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
3/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
0.00%
0/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
41.5%
22/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
24.5%
13/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
26.4%
14/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
24.5%
13/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
9.8%
5/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
7.5%
4/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
11.3%
6/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.9%
2/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
17.0%
9/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
18.9%
10/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
22.6%
12/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
30.2%
16/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
5.7%
3/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
9.4%
5/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
13.2%
7/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
2.0%
1/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
7.5%
4/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
11.3%
6/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
|
Vascular disorders
Hypertension
|
13.7%
7/51 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
3.8%
2/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
1.9%
1/53 • All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months.
All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. DCO = Data cutoff; EOS = End of study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER