Trial Outcomes & Findings for A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors (NCT NCT05071183)
NCT ID: NCT05071183
Last Updated: 2024-04-02
Results Overview
Number of participants with first cycle DLTs to determine Mean Tolderable Dose (MTD) and/or RP2D. A DLT is defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications that meets the criteria defined in each subprotocol. The MTD is defined as the highest dose level of repotrectinib given in combination with other anticancer therapy observed to cause a DLT in fewer than 33% of the treated subjects in the first treatment cycle (i.e., Cycle 1).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
From initial dose to end of first cycle of treatment, approximately 28 days
Results posted on
2024-04-02
Participant Flow
9 participants enrolled and treated in phase 1. No participants enrolled in phase 2.
Participant milestones
| Measure |
Dose Level 1
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
2
|
Reasons for withdrawal
| Measure |
Dose Level 1
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
0
|
|
Overall Study
Other Reasons
|
1
|
3
|
2
|
Baseline Characteristics
A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=2 Participants
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=5 Participants
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
n=2 Participants
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.5 Years
STANDARD_DEVIATION 21.92 • n=5 Participants
|
61.8 Years
STANDARD_DEVIATION 12.74 • n=7 Participants
|
60.5 Years
STANDARD_DEVIATION 13.44 • n=5 Participants
|
61.0 Years
STANDARD_DEVIATION 12.84 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From initial dose to end of first cycle of treatment, approximately 28 daysPopulation: All treated participants
Number of participants with first cycle DLTs to determine Mean Tolderable Dose (MTD) and/or RP2D. A DLT is defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications that meets the criteria defined in each subprotocol. The MTD is defined as the highest dose level of repotrectinib given in combination with other anticancer therapy observed to cause a DLT in fewer than 33% of the treated subjects in the first treatment cycle (i.e., Cycle 1).
Outcome measures
| Measure |
Dose Level 1
n=2 Participants
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=5 Participants
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
n=2 Participants
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From screening to end of treatment approximately 10 monthsPopulation: Efficacy Evaluable Set - all participants who (1) received at least one dose of study treatment with repotrectinib; (2) KRAS mutation determined by a qPCR or NGS test performed in a CLIA laboratory or equivalently accredited diagnostic lab; (3) have a baseline tumor assessment with measurable disease and have at least 1 on-study tumor assessment per RECIST v1.1; and (4) have no major protocol violations that could affect efficacy. (Dose Level 1 and -2a did not meet efficacy evaluable criteria)
The ORR will be defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR). A confirmed response is a response that persists on a repeat imaging performed at least 4 weeks after initial documentation of response. Participants with a confirmed objective response (CR or PR) will be referred to as responders. Radiographic confirmation of objective tumor response (CR or PR) or disease progression will be based on RECIST v1.1. The ORR will be reported as the percentage of responders by RECIST v1.1 along with the corresponding two-sided 95% Clopper-Pearson exact CI. Complete Response (CR) = Disappearance of all target lesions Partial Response (PR) = \>=30% decrease in the sum diameters of target lesions.
Outcome measures
| Measure |
Dose Level 1
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=4 Participants
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
Overall Response Rate (ORR) Assessed the Investigator Using RECIST v1.1.
|
—
|
0 Percentage of Participants
Interval 0.0 to 60.2
|
—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 1 Day 22Population: All Treated Participants with evaluable pharmacokinetic measurements.
Cmax is defined as maximum plasma concentration of the drug.
Outcome measures
| Measure |
Dose Level 1
n=2 Participants
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=5 Participants
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
n=2 Participants
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
Cmax of Repotrectinib
Cycle 1 Day 1
|
656.85 ng/mL
Geometric Coefficient of Variation 37.88
|
570.86 ng/mL
Geometric Coefficient of Variation 66.02
|
569.27 ng/mL
Geometric Coefficient of Variation 20.26
|
|
Cmax of Repotrectinib
Cycle 1 Day 22
|
—
|
411.83 ng/mL
Geometric Coefficient of Variation 49.37
|
—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 1 Day 22Population: All Treated Participants with evaluable pharmacokinetic measurements.
Tmax is defined is the time to maximum plasma concentration
Outcome measures
| Measure |
Dose Level 1
n=2 Participants
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=5 Participants
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
n=2 Participants
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
Tmax of Repotrecitinib
Cycle 1 Day 1
|
3.00 hours (h)
Interval 2.0 to 4.0
|
2.00 hours (h)
Interval 1.0 to 6.0
|
4.00 hours (h)
Interval 4.0 to 4.0
|
|
Tmax of Repotrecitinib
Cycle 1 Day 22
|
—
|
3.00 hours (h)
Interval 2.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 1 Day 22Population: All Treated Participants with evaluable pharmacokinetic measurements.
Area under the plasma concentration time-curve. AUC from time 0 to 24 hours after dose.
Outcome measures
| Measure |
Dose Level 1
n=2 Participants
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=5 Participants
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
n=2 Participants
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
AUC 0-24 of Repotrecitinib
Cycle 1 Day 1
|
6208.74 h*ng/mL
Geometric Coefficient of Variation 82.59
|
6692.13 h*ng/mL
Geometric Coefficient of Variation 57.48
|
8327.26 h*ng/mL
Geometric Coefficient of Variation 25.27
|
|
AUC 0-24 of Repotrecitinib
Cycle 1 Day 22
|
—
|
5223.89 h*ng/mL
Geometric Coefficient of Variation 31.06
|
—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 1 Day 22Population: All Treated Participants with evaluable pharmacokinetic measurements.
Cmax is defined as maximum plasma concentration of the drug.
Outcome measures
| Measure |
Dose Level 1
n=2 Participants
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=5 Participants
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
n=2 Participants
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
Cmax of Trametinib
Cycle 1 Day 1
|
15.24 ng/mL
Geometric Coefficient of Variation 20.55
|
3.30 ng/mL
Geometric Coefficient of Variation 69.58
|
2.60 ng/mL
Geometric Coefficient of Variation 29.74
|
|
Cmax of Trametinib
Cycle 1 Day 22
|
—
|
10.55 ng/mL
Geometric Coefficient of Variation 56.36
|
—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 1 Day 22Population: All Treated Participants with evaluable pharmacokinetic measurements.
Tmax is defined is the time to maximum plasma concentration
Outcome measures
| Measure |
Dose Level 1
n=2 Participants
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=5 Participants
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
n=2 Participants
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
Tmax of Trametinib
Cycle 1 Day 1
|
1.50 hours (h)
Interval 1.0 to 2.0
|
2.00 hours (h)
Interval 1.0 to 2.0
|
2.00 hours (h)
Interval 2.0 to 2.0
|
|
Tmax of Trametinib
Cycle 1 Day 22
|
—
|
2.50 hours (h)
Interval 1.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 1 Day 22Population: All Treated Participants with evaluable pharmacokinetic measurements.
Area under the plasma concentration time-curve. AUC from time 0 to 24 hours after dose.
Outcome measures
| Measure |
Dose Level 1
n=2 Participants
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=5 Participants
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
n=2 Participants
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
AUC 0-24 of Trametinib
Cycle 1 Day 1
|
88.77 h*ng/mL
Geometric Coefficient of Variation 6.48
|
20.58 h*ng/mL
Geometric Coefficient of Variation 36.19
|
19.27 h*ng/mL
Geometric Coefficient of Variation 13.47
|
|
AUC 0-24 of Trametinib
Cycle 1 Day 22
|
—
|
197.45 h*ng/mL
Geometric Coefficient of Variation 45.52
|
—
|
Adverse Events
Dose Level 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Dose Level 2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 2 deaths
Dose Level -2a
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level 1
n=2 participants at risk
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=5 participants at risk
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
n=2 participants at risk
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Dose Level 1
n=2 participants at risk
Repotrectinib 120 mg QD, Trametinib 2 mg QD
|
Dose Level 2
n=5 participants at risk
Repotrectinib 120 mg QD, Trametinib 1.0 mg QD
|
Dose Level -2a
n=2 participants at risk
Repotrectinib 160 mg QD, Trametinib 1.0 mg QD
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
2/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Catheter site oedema
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Amylase increased
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Lipase increased
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
White blood cell count increased
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Aphasia
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Paraesthesia
|
50.0%
1/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/2 • From first dose to 28 days after last dose, approximately 9.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER