Trial Outcomes & Findings for Study of Magrolimab Given Together With FOLFIRI/Bevacizumab (BEV) in Participants With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC) (NCT NCT05330429)
NCT ID: NCT05330429
Last Updated: 2025-07-01
Results Overview
DLT was defined as any, * Grade 3 or higher hematologic toxicity including, serious hemolytic anemia, grade 4 neutropenia lasting \> 7 days * An event meeting Hy's Law criteria: * Treatment-emergent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (≥ 3 x ULN) and, * Treatment-emergent total bilirubin elevation (\> 2 x ULN), and absence of cholestasis (defined as alkaline phosphatase \< 2 x ULN), and * No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, alcohol ingestion, congestive heart failure, worsening liver metastases, hemolysis)) * Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment baseline during the DLT-assessment period * Grade 3 fatigue lasting \> 7 days * In the opinion of the investigator, the AE was at least possibly related to magrolimab
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
First dose date up to 28 days
Results posted on
2025-07-01
Participant Flow
124 participants were screened.
Participants were enrolled at study sites in Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Spain, the United States and Puerto Rico.
Participant milestones
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m² IV bolus on first day, followed by 2400 mg/m² over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
44
|
23
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
44
|
23
|
Reasons for withdrawal
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m² IV bolus on first day, followed by 2400 mg/m² over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
4
|
33
|
12
|
|
Overall Study
Death
|
5
|
2
|
4
|
|
Overall Study
Withdrew Consent
|
0
|
5
|
4
|
|
Overall Study
Investigator's Discretion
|
0
|
1
|
3
|
|
Overall Study
Subject Decision
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Study of Magrolimab Given Together With FOLFIRI/Bevacizumab (BEV) in Participants With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
Baseline characteristics by cohort
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=10 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=44 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=23 Participants
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
59 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
56 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
57 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 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
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 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
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Hong Kong
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: First dose date up to 28 daysPopulation: Participants in DLT-Evaluable Analysis Set were analyzed. DLT-Evaluable Analysis Set was defined as all participants in Safety Run-in cohort who met one of the following criteria in the DLT-evaluable period (defined as the first 28 days): * Participant experienced a DLT at any time after initiation of first infusion of magrolimab. * Participant did not experience a DLT and completes at least 3 infusions of magrolimab and at least 2 doses of bevacizumab and FOLFIRI in Safety Run-in Cohort.
DLT was defined as any, * Grade 3 or higher hematologic toxicity including, serious hemolytic anemia, grade 4 neutropenia lasting \> 7 days * An event meeting Hy's Law criteria: * Treatment-emergent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (≥ 3 x ULN) and, * Treatment-emergent total bilirubin elevation (\> 2 x ULN), and absence of cholestasis (defined as alkaline phosphatase \< 2 x ULN), and * No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, alcohol ingestion, congestive heart failure, worsening liver metastases, hemolysis)) * Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment baseline during the DLT-assessment period * Grade 3 fatigue lasting \> 7 days * In the opinion of the investigator, the AE was at least possibly related to magrolimab
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=6 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Safety Run-in Cohort: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: First dose date up to last dose date (up to 36 weeks) plus 30 daysPopulation: Participants in the Safety Run-in Cohort in the Safety Analysis Set were analyzed. The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Treatment-emergent adverse events (TEAEs) were defined as any AE that begun on or after the date of first dose of study drug up to the date of last dose of study treatment plus 30 days or the day before initiation of subsequent anticancer therapy, whichever came first. An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily have a causal relationship with the treatment.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=10 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Safety Run-in Cohort: Percentage of Participants Experiencing Adverse Events (AEs) According to the NCI-CTCAE Version 5.0
|
100.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: First dose date up to last dose date (up to 36 weeks) plus 30 daysPopulation: Participants in the Safety Run-in Cohort in the Safety Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade after the date of first dose of study drug up to the date of last dose of study treatment plus 30 days or the day before initiation of subsequent anticancer therapy, whichever came first.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=10 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Safety Run-in Cohort: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI-CTCAE Version 5.0
Any Grade 1 or Higher
|
100.0 percentage of participants
|
—
|
|
Safety Run-in Cohort: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI-CTCAE Version 5.0
Grade 3 or 4
|
90.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Up to 83.4 weeksPopulation: Participants in the Randomized Cohorts in the Intent-to-treat Analysis Set were analyzed. Intent-to-treat Analysis Set included all participants who were randomized in the study.
PFS was defined as the time from the date of randomization until the earliest date of documented disease progression (PD) as determined by investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1), or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier (KM) estimates were used in outcome measure analysis.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=44 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=23 Participants
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Randomized Cohort: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
6.2 months
Interval 6.0 to
Upper limit of confidence interval (CI) was not estimable due to low number of participants with events.
|
6.7 months
Interval 3.9 to
Upper limit of CI was not estimable due to low number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 83.4 weeksPopulation: Participants in the Randomized Cohorts in the Intent-to-Treat Analysis Set were analyzed.
ORR was defined as the percentage of participants who achieve complete response (CR) or partial response (PR) that was confirmed at least 4 weeks after initial documentation of response, as determined by investigator assessment per RECIST, Version 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=44 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=23 Participants
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Randomized Cohort: Objective Response Rate (ORR) as Determined by Investigator Assessment Using RECIST Version 1.1
|
13.6 percentage of participants
Interval 5.2 to 27.4
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
SECONDARY outcome
Timeframe: Up to 83.4 weeksPopulation: Participants in the Randomized Cohorts in the Intent-to-Treat Analysis Set with objective response were analyzed.
DOR was defined as time from first documentation of CR or PR to the earliest date of documented disease progression as determined by investigator assessment, per RECIST V1.1, or death from any cause, whichever occurred first. PD was defined in outcome measure #4. CR and PR were defined in outcome measure #5. KM estimates were used in outcome measure analysis.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=6 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Randomized Cohort: Duration of Response (DOR) as Determined by Investigator Assessment Per RECIST Version 1.1
|
NA months
Median, lower and upper limit of CI were not estimable due to low number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Up to 83.4 weeksPopulation: Participants in the Randomized Cohort in the Intent-to-Treat Analysis Set were analyzed.
OS was defined as time from date of randomization to death from any cause. KM estimates were used in outcome measure analysis.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=44 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=23 Participants
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Randomized Cohort: Overall Survival (OS)
|
NA months
Median, lower and upper limit of CI were not estimable due to low number of participants with events.
|
8.2 months
Interval 6.1 to
Upper limit of CI were not estimable due to low number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4 and last cycle (Cycle 8) (Each cycle was of 28 days)Population: Participants in the Randomized cohort in the Intent-to-treat Analysis Set with available data were analyzed. Data was collected until Cycle 8.
EORTC QLQ-C30 is a quality of life (QOL) questionnaire for cancer participants, that has 30 items. 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties). Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicated a higher level of symptoms (i.e. a worse state of the participant).
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=38 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=18 Participants
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Global Health Status / QoL: Baseline
|
68.0 Score on a scale
Standard Deviation 20.1
|
69.0 Score on a scale
Standard Deviation 18.0
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Global Health Status / QoL: Change from Baseline at Cycle 2 Day 1
|
-1.3 Score on a scale
Standard Deviation 20.9
|
-2.1 Score on a scale
Standard Deviation 17.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Global Health Status / QoL: Change from Baseline at Cycle 3 Day 1
|
1.7 Score on a scale
Standard Deviation 17.8
|
5.4 Score on a scale
Standard Deviation 15.2
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Global Health Status / QoL: Change from Baseline at Cycle 4 Day 1
|
0.4 Score on a scale
Standard Deviation 19.8
|
-3.8 Score on a scale
Standard Deviation 13.6
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Global Health Status / QoL: Change from Baseline at Cycle 8 Day 1
|
0.0 Score on a scale
Standard Deviation 23.6
|
-16.7 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Physical Functioning: Baseline
|
83.5 Score on a scale
Standard Deviation 16.8
|
85.2 Score on a scale
Standard Deviation 15.3
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Physical Functioning: Change from Baseline at Cycle 2 Day 1
|
-5.7 Score on a scale
Standard Deviation 11.9
|
-0.8 Score on a scale
Standard Deviation 6.4
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Physical Functioning: Change from Baseline at Cycle 3 Day 1
|
-0.8 Score on a scale
Standard Deviation 13.9
|
-0.5 Score on a scale
Standard Deviation 4.9
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Physical Functioning: Change from Baseline at Cycle 4 Day 1
|
-3.2 Score on a scale
Standard Deviation 8.1
|
0.0 Score on a scale
Standard Deviation 11.2
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Physical Functioning: Cycle 8 Day 1
|
0.0 Score on a scale
Standard Deviation 0.0
|
-26.7 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Role Functioning: Baseline
|
74.1 Score on a scale
Standard Deviation 24.4
|
88.9 Score on a scale
Standard Deviation 15.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Role Functioning: Change from Baseline at Cycle 2 Day 1
|
-3.5 Score on a scale
Standard Deviation 19.9
|
-13.5 Score on a scale
Standard Deviation 22.9
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Role Functioning: Change from Baseline at Cycle 3 Day 1
|
3.3 Score on a scale
Standard Deviation 25.5
|
-6.0 Score on a scale
Standard Deviation 16.8
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Role Functioning: Change from Baseline at Cycle 4 Day 1
|
-1.6 Score on a scale
Standard Deviation 16.6
|
-10.6 Score on a scale
Standard Deviation 22.7
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Role Functioning: Change from Baseline at Cycle 8 Day 1
|
0.0 Score on a scale
Standard Deviation 0.0
|
-100.0 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Emotional Functioning: Baseline
|
75.4 Score on a scale
Standard Deviation 19.6
|
71.3 Score on a scale
Standard Deviation 23.4
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Emotional Functioning: Change from Baseline at Cycle 2 Day 1
|
9.1 Score on a scale
Standard Deviation 15.2
|
6.3 Score on a scale
Standard Deviation 17.3
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Emotional Functioning: Change from Baseline at Cycle 3 Day 1
|
8.0 Score on a scale
Standard Deviation 9.2
|
10.7 Score on a scale
Standard Deviation 14.8
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Emotional Functioning: Change from Baseline at Cycle 4 Day 1
|
5.6 Score on a scale
Standard Deviation 12.5
|
6.8 Score on a scale
Standard Deviation 18.2
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Emotional Functioning: Change from Baseline at Cycle 8 Day 1
|
12.5 Score on a scale
Standard Deviation 5.9
|
0.0 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Cognitive Functioning: Baseline
|
89.9 Score on a scale
Standard Deviation 15.3
|
88.0 Score on a scale
Standard Deviation 17.0
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Cognitive Functioning: Change from Baseline at Cycle 2 Day 1
|
-0.5 Score on a scale
Standard Deviation 12.1
|
-2.1 Score on a scale
Standard Deviation 17.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Cognitive Functioning: Change from Baseline at Cycle 3 Day 1
|
0.7 Score on a scale
Standard Deviation 17.7
|
2.4 Score on a scale
Standard Deviation 17.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Cognitive Functioning: Change from Baseline at Cycle 4 Day 1
|
-4.0 Score on a scale
Standard Deviation 19.7
|
-3.0 Score on a scale
Standard Deviation 10.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Cognitive Functioning: Change from Baseline at Cycle 8 Day 1
|
0.0 Score on a scale
Standard Deviation 0.0
|
16.7 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Social Functioning: Baseline
|
71.5 Score on a scale
Standard Deviation 21.9
|
82.4 Score on a scale
Standard Deviation 25.2
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Social Functioning: Change from Baseline at Cycle 2 Day 1
|
2.0 Score on a scale
Standard Deviation 24.2
|
1.0 Score on a scale
Standard Deviation 18.7
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Social Functioning: Change from Baseline at Cycle 3 Day 1
|
6.0 Score on a scale
Standard Deviation 25.4
|
-3.6 Score on a scale
Standard Deviation 16.2
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Social Functioning: Change from Baseline at Cycle 4 Day 1
|
4.0 Score on a scale
Standard Deviation 16.6
|
1.5 Score on a scale
Standard Deviation 13.9
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Functional Scales: Social Functioning: Change from Baseline at Cycle 8 Day 1
|
8.3 Score on a scale
Standard Deviation 11.8
|
-50.0 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Fatigue: Baseline
|
31.0 Score on a scale
Standard Deviation 22.1
|
24.1 Score on a scale
Standard Deviation 16.3
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Fatigue: Change from Baseline at Cycle 2 Day 1
|
7.7 Score on a scale
Standard Deviation 19.7
|
4.2 Score on a scale
Standard Deviation 16.2
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Fatigue: Change from Baseline at Cycle 3 Day 1
|
4.9 Score on a scale
Standard Deviation 20.1
|
1.6 Score on a scale
Standard Deviation 17.4
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Fatigue: Change from Baseline at Cycle 4 Day 1
|
5.8 Score on a scale
Standard Deviation 16.3
|
7.1 Score on a scale
Standard Deviation 15.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Fatigue: Change from Baseline at Cycle 8 Day 1
|
-5.6 Score on a scale
Standard Deviation 39.3
|
55.6 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Nausea and Vomiting: Baseline
|
4.8 Score on a scale
Standard Deviation 11.6
|
3.7 Score on a scale
Standard Deviation 10.8
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Nausea and Vomiting: Change from Baseline at Cycle 2 Day 1
|
6.1 Score on a scale
Standard Deviation 18.1
|
11.5 Score on a scale
Standard Deviation 18.0
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Nausea and Vomiting: Change from Baseline at Cycle 3 Day 1
|
3.3 Score on a scale
Standard Deviation 8.3
|
3.6 Score on a scale
Standard Deviation 9.6
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Nausea and Vomiting: Change from Baseline at Cycle 4 Day 1
|
6.3 Score on a scale
Standard Deviation 11.2
|
3.0 Score on a scale
Standard Deviation 6.7
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Nausea and Vomiting: Change from Baseline at Cycle 8 Day 1
|
0.0 Score on a scale
Standard Deviation 0.0
|
16.7 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Pain: Baseline
|
23.7 Score on a scale
Standard Deviation 23.8
|
19.4 Score on a scale
Standard Deviation 29.8
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Pain: Change from Baseline at Cycle 2 Day 1
|
-4.0 Score on a scale
Standard Deviation 18.6
|
0.0 Score on a scale
Standard Deviation 17.2
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Pain: Change from Baseline at Cycle 3 Day 1
|
-6.7 Score on a scale
Standard Deviation 19.2
|
-11.9 Score on a scale
Standard Deviation 20.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Pain: Change from Baseline at Cycle 4 Day 1
|
-1.6 Score on a scale
Standard Deviation 19.7
|
-9.1 Score on a scale
Standard Deviation 17.3
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Pain: Change from Baseline at Cycle 8 Day 1
|
-16.7 Score on a scale
Standard Deviation 0.0
|
33.3 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Dyspnoea: Baseline
|
7.9 Score on a scale
Standard Deviation 18.1
|
9.3 Score on a scale
Standard Deviation 15.4
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Dyspnoea: Change from Baseline at Cycle 2 Day 1
|
11.1 Score on a scale
Standard Deviation 28.5
|
2.1 Score on a scale
Standard Deviation 14.8
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Dyspnoea: Change from Baseline at Cycle 3 Day 1
|
5.3 Score on a scale
Standard Deviation 12.5
|
-2.4 Score on a scale
Standard Deviation 8.9
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Dyspnoea: Change from Baseline at Cycle 4 Day 1
|
11.1 Score on a scale
Standard Deviation 16.1
|
6.1 Score on a scale
Standard Deviation 13.5
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Dyspnoea: Change from Baseline at Cycle 8 Day 1
|
16.7 Score on a scale
Standard Deviation 23.6
|
33.3 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Insomnia: Baseline
|
29.8 Score on a scale
Standard Deviation 31.8
|
31.5 Score on a scale
Standard Deviation 29.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Insomnia: Change from Baseline at Cycle 2 Day 1
|
-4.0 Score on a scale
Standard Deviation 20.0
|
-2.1 Score on a scale
Standard Deviation 19.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Insomnia: Change from Baseline at Cycle 3 Day 1
|
-5.3 Score on a scale
Standard Deviation 22.9
|
-7.1 Score on a scale
Standard Deviation 29.8
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Insomnia: Change from Baseline at Cycle 4 Day 1
|
-3.2 Score on a scale
Standard Deviation 25.6
|
-12.1 Score on a scale
Standard Deviation 30.8
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Insomnia: Change from Baseline at Cycle 8 Day 1
|
-16.7 Score on a scale
Standard Deviation 70.7
|
0.0 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Appetite Loss: Baseline
|
21.1 Score on a scale
Standard Deviation 28.4
|
11.1 Score on a scale
Standard Deviation 22.9
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Appetite Loss: Change from Baseline at Cycle 2 Day 1
|
5.1 Score on a scale
Standard Deviation 20.6
|
6.2 Score on a scale
Standard Deviation 21.8
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Appetite Loss: Change from Baseline at Cycle 3 Day 1
|
5.3 Score on a scale
Standard Deviation 22.9
|
2.4 Score on a scale
Standard Deviation 20.5
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Appetite Loss: Change from Baseline at Cycle 4 Day 1
|
1.6 Score on a scale
Standard Deviation 24.7
|
9.1 Score on a scale
Standard Deviation 21.6
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Appetite Loss: Change from Baseline at Cycle 8 Day 1
|
0.0 Score on a scale
Standard Deviation 0.0
|
33.3 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Constipation: Baseline
|
7.9 Score on a scale
Standard Deviation 18.1
|
13.0 Score on a scale
Standard Deviation 25.9
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Constipation: Change from Baseline at Cycle 2 Day 1
|
12.1 Score on a scale
Standard Deviation 26.1
|
2.1 Score on a scale
Standard Deviation 25.7
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Constipation: Change from Baseline at Cycle 3 Day 1
|
14.7 Score on a scale
Standard Deviation 25.6
|
0.0 Score on a scale
Standard Deviation 37.0
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Constipation: Change from Baseline at Cycle 4 Day 1
|
12.7 Score on a scale
Standard Deviation 24.7
|
6.1 Score on a scale
Standard Deviation 25.0
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Constipation: Change from Baseline at Cycle 8 Day 1
|
0.0 Score on a scale
Standard Deviation 0.0
|
66.7 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Diarrhoea: Baseline
|
14.0 Score on a scale
Standard Deviation 24.1
|
5.6 Score on a scale
Standard Deviation 12.8
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Diarrhoea: Change from Baseline at Cycle 2 Day 1
|
12.1 Score on a scale
Standard Deviation 20.1
|
16.7 Score on a scale
Standard Deviation 21.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Diarrhoea: Change from Baseline at Cycle 3 Day 1
|
5.3 Score on a scale
Standard Deviation 26.7
|
16.7 Score on a scale
Standard Deviation 17.3
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Diarrhoea: Change from Baseline at Cycle 4 Day 1
|
9.5 Score on a scale
Standard Deviation 26.1
|
15.2 Score on a scale
Standard Deviation 17.4
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Diarrhoea: Change from Baseline at Cycle 8 Day 1
|
33.3 Score on a scale
Standard Deviation 0.0
|
66.7 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Financial Difficulties: Baseline
|
26.3 Score on a scale
Standard Deviation 35.6
|
13.0 Score on a scale
Standard Deviation 23.3
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Financial Difficulties: Change from Baseline at Cycle 2 Day 1
|
-6.1 Score on a scale
Standard Deviation 24.2
|
2.1 Score on a scale
Standard Deviation 8.3
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Financial Difficulties: Change from Baseline at Cycle 3 Day 1
|
-8.0 Score on a scale
Standard Deviation 24.1
|
7.1 Score on a scale
Standard Deviation 19.3
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Financial Difficulties: Change from Baseline at Cycle 4 Day 1
|
-3.2 Score on a scale
Standard Deviation 25.6
|
3.0 Score on a scale
Standard Deviation 10.1
|
|
Randomized Cohort: Change From Baseline of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) - Core Questionnaire EORTC-QLQ-C30 Score
Symptom Scales / Items: Financial Difficulties: Change from Baseline at Cycle 8 Day 1
|
0.0 Score on a scale
Standard Deviation 0.0
|
0.0 Score on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
SECONDARY outcome
Timeframe: Day 1 of Cycles 2, 3, 4 and last cycle (Cycle 8) (Each cycle is of 28 days)Population: Participants in the Randomized Cohort in the Intent-to-treat Analysis Set with available data were analyzed.
EQ-5D-5L was an instrument for use as a measure of health outcome. The EQ-5D-5L consisted of 2 sections: EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). EQ-5D comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Number of participants per category were reported.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=38 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=17 Participants
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Baseline · No Problems
|
27 Participants
|
12 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Baseline · Slight Problems
|
5 Participants
|
4 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Baseline · Moderate Problems
|
5 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Baseline · Severe Problems
|
1 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Baseline · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 2 Day 1 · No Problems
|
21 Participants
|
10 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 2 Day 1 · Slight Problems
|
6 Participants
|
6 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 2 Day 1 · Moderate Problems
|
4 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 2 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 2 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 3 Day 1 · No Problems
|
20 Participants
|
9 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 3 Day 1 · Slight Problems
|
3 Participants
|
7 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 3 Day 1 · Moderate Problems
|
2 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 3 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 3 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 4 Day 1 · No Problems
|
15 Participants
|
10 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 4 Day 1 · Slight Problems
|
3 Participants
|
2 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 4 Day 1 · Moderate Problems
|
4 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 4 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 4 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 8 Day 1 · No Problems
|
2 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 8 Day 1 · Slight Problems
|
0 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 8 Day 1 · Moderate Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 8 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Mobility: Cycle 8 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Baseline · No Problems
|
32 Participants
|
17 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Baseline · Slight Problems
|
4 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Baseline · Moderate Problems
|
1 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Baseline · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Baseline · Extreme Problems
|
1 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 2 Day 1 · No Problems
|
25 Participants
|
15 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 2 Day 1 · Slight Problems
|
5 Participants
|
2 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 2 Day 1 · Moderate Problems
|
1 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 2 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 2 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 3 Day 1 · No Problems
|
24 Participants
|
16 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 3 Day 1 · Slight Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 3 Day 1 · Moderate Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 3 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 3 Day 1 · Extreme Problems
|
1 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 4 Day 1 · No Problems
|
20 Participants
|
11 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 4 Day 1 · Slight Problems
|
0 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 4 Day 1 · Moderate Problems
|
2 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 4 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 4 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 8 Day 1 · No Problems
|
2 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 8 Day 1 · Slight Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 8 Day 1 · Moderate Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 8 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Self-Care: Cycle 8 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Baseline · No Problems
|
18 Participants
|
11 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Baseline · Slight Problems
|
14 Participants
|
3 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Baseline · Moderate Problems
|
6 Participants
|
2 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Baseline · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Baseline · Extreme Problems
|
0 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 2 Day 1 · No Problems
|
15 Participants
|
10 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 2 Day 1 · Slight Problems
|
11 Participants
|
5 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 2 Day 1 · Moderate Problems
|
4 Participants
|
2 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 2 Day 1 · Severe Problems
|
1 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 2 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 3 Day 1 · No Problems
|
17 Participants
|
9 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 3 Day 1 · Slight Problems
|
7 Participants
|
5 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 3 Day 1 · Moderate Problems
|
1 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 3 Day 1 · Severe Problems
|
0 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 3 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 4 Day 1 · No Problems
|
13 Participants
|
10 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 4 Day 1 · Slight Problems
|
6 Participants
|
2 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 4 Day 1 · Moderate Problems
|
3 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 4 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 4 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 8 Day 1 · No Problems
|
2 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 8 Day 1 · Slight Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 8 Day 1 · Moderate Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 8 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Usual Activities: Cycle 8 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Baseline · No Problems
|
14 Participants
|
10 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Baseline · Slight Problems
|
15 Participants
|
2 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Baseline · Moderate Problems
|
7 Participants
|
4 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Baseline · Severe Problems
|
2 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Baseline · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 2 Day 1 · No Problems
|
16 Participants
|
9 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 2 Day 1 · Slight Problems
|
9 Participants
|
3 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 2 Day 1 · Moderate Problems
|
5 Participants
|
4 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 2 Day 1 · Severe Problems
|
1 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 2 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 3 Day 1 · No Problems
|
14 Participants
|
10 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 3 Day 1 · Slight Problems
|
11 Participants
|
3 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 3 Day 1 · Moderate Problems
|
0 Participants
|
3 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 3 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 3 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 4 Day 1 · No Problems
|
13 Participants
|
8 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 4 Day 1 · Slight Problems
|
6 Participants
|
4 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 4 Day 1 · Moderate Problems
|
2 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 4 Day 1 · Severe Problems
|
1 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 4 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 8 Day 1 · No Problems
|
2 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 8 Day 1 · Slight Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 8 Day 1 · Moderate Problems
|
0 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 8 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Pain/Discomfort: Cycle 8 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Baseline · No Problems
|
25 Participants
|
7 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Baseline · Slight Problems
|
10 Participants
|
9 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Baseline · Moderate Problems
|
2 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Baseline · Severe Problems
|
1 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Baseline · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 2 Day 1 · No Problems
|
21 Participants
|
9 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 2 Day 1 · Slight Problems
|
9 Participants
|
4 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 2 Day 1 · Moderate Problems
|
1 Participants
|
4 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 2 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 2 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 3 Day 1 · No Problems
|
15 Participants
|
12 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 3 Day 1 · Slight Problems
|
8 Participants
|
2 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 3 Day 1 · Moderate Problems
|
2 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 3 Day 1 · Severe Problems
|
0 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 3 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 4 Day 1 · No Problems
|
11 Participants
|
7 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 4 Day 1 · Slight Problems
|
11 Participants
|
4 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 4 Day 1 · Moderate Problems
|
0 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 4 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 4 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 8 Day 1 · No Problems
|
2 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 8 Day 1 · Slight Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 8 Day 1 · Moderate Problems
|
0 Participants
|
1 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 8 Day 1 · Severe Problems
|
0 Participants
|
0 Participants
|
|
Randomized Cohort: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Anxiety/Depression: Cycle 8 Day 1 · Extreme Problems
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4 and last cycle (Cycle 8) (Each cycle is of 28 days)Population: Participants in the Randomized Cohort in the Intent-to-treat Analysis Set with available data were analyzed.
The EQ-VAS recorded the participants' self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The scale range from 0 to 100, where '100' rating denotes the best health and '0' rating denotes the worst health. The EQ-VAS is used as a quantitative measure of health outcome that reflects the participants' own judgment.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=38 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=17 Participants
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Randomized Cohort: Change From Baseline in the EuroQoL Visual Analogue Scale (EQ-VAS) Score
Baseline
|
72.2 Units on a scale
Standard Deviation 17.58
|
75.9 Units on a scale
Standard Deviation 12.78
|
|
Randomized Cohort: Change From Baseline in the EuroQoL Visual Analogue Scale (EQ-VAS) Score
Change from Baseline at Cycle 2 Day 1
|
-3.0 Units on a scale
Standard Deviation 14.97
|
-4.8 Units on a scale
Standard Deviation 17.55
|
|
Randomized Cohort: Change From Baseline in the EuroQoL Visual Analogue Scale (EQ-VAS) Score
Change from Baseline at Cycle 3 Day 1
|
3.6 Units on a scale
Standard Deviation 17.47
|
-4.5 Units on a scale
Standard Deviation 15.14
|
|
Randomized Cohort: Change From Baseline in the EuroQoL Visual Analogue Scale (EQ-VAS) Score
Change from Baseline at Cycle 4 Day 1
|
-0.3 Units on a scale
Standard Deviation 16.63
|
-3.7 Units on a scale
Standard Deviation 12.32
|
|
Randomized Cohort: Change From Baseline in the EuroQoL Visual Analogue Scale (EQ-VAS) Score
Change from Baseline at Cycle 8 Day 1
|
5.0 Units on a scale
Standard Deviation 7.07
|
-44.0 Units on a scale
Standard Deviation NA
Standard deviation cannot be calculated for one participant.
|
SECONDARY outcome
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4 and last cycle (Cycle 8) (Each cycle is of 28 days)Population: Participants in the Randomized Cohort in the Intent-to-Treat Analysis Set with available data were analyzed.
The FCSI was a set of brief, clinically relevant, colorectal cancer symptoms for assessing symptomatic response. It comprised the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions were combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items were scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items was transformed to a 0-100 scale, and the average for each of the 3 subscales was calculated; high scores illustrated an improved state.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=38 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=17 Participants
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Randomized Cohort: Change From Baseline of the Functional Assessment of Cancer Therapy (FACT) Colorectal Symptom Index (FCSI) Score
FCSI Score: Baseline
|
27.1 Score on a scale
Standard Deviation 5.8
|
27.8 Score on a scale
Standard Deviation 4.8
|
|
Randomized Cohort: Change From Baseline of the Functional Assessment of Cancer Therapy (FACT) Colorectal Symptom Index (FCSI) Score
FCSI Score: Change from Baseline at Cycle 2 Day 1
|
-1.1 Score on a scale
Standard Deviation 3.7
|
-0.3 Score on a scale
Standard Deviation 3.4
|
|
Randomized Cohort: Change From Baseline of the Functional Assessment of Cancer Therapy (FACT) Colorectal Symptom Index (FCSI) Score
FCSI Score: Change from Baseline at Cycle 3 Day 1
|
-0.6 Score on a scale
Standard Deviation 3.5
|
-0.9 Score on a scale
Standard Deviation 5.0
|
|
Randomized Cohort: Change From Baseline of the Functional Assessment of Cancer Therapy (FACT) Colorectal Symptom Index (FCSI) Score
FCSI Score: Change from Baseline at Cycle 4 Day 1
|
-0.6 Score on a scale
Standard Deviation 4.1
|
0.4 Score on a scale
Standard Deviation 4.6
|
|
Randomized Cohort: Change From Baseline of the Functional Assessment of Cancer Therapy (FACT) Colorectal Symptom Index (FCSI) Score
FCSI Score: Change from Baseline at Cycle 8 Day 1
|
-1.0 Score on a scale
Standard Deviation 2.8
|
—
|
SECONDARY outcome
Timeframe: Predose: Day 15, 29, 57, 113 and 169; Postdose: Day 57 (1 hour)Population: Participants in the Pharmacokinetic (PK) Analysis Set with available data were analyzed. The PK Analysis Set was defined as all participants who received any amount of magrolimab and have at least 1 measurable posttreatment serum concentration of magrolimab.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=9 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=36 Participants
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Safety Run-in and Randomized Cohorts: Magrolimab Concentration Versus Time
Day 15: Predose
|
187 μg/mL
Standard Deviation 41.7
|
186 μg/mL
Standard Deviation 55.0
|
|
Safety Run-in and Randomized Cohorts: Magrolimab Concentration Versus Time
Day 29: Predose
|
581 μg/mL
Standard Deviation 270.0
|
412 μg/mL
Standard Deviation 163.0
|
|
Safety Run-in and Randomized Cohorts: Magrolimab Concentration Versus Time
Day 57: Predose
|
889 μg/mL
Standard Deviation 236.0
|
610 μg/mL
Standard Deviation 204.0
|
|
Safety Run-in and Randomized Cohorts: Magrolimab Concentration Versus Time
Day 57: 1 hour Postdose
|
1850 μg/mL
Standard Deviation 385.0
|
1220 μg/mL
Standard Deviation 360.0
|
|
Safety Run-in and Randomized Cohorts: Magrolimab Concentration Versus Time
Day 113: Predose
|
469 μg/mL
Standard Deviation 134.0
|
310 μg/mL
Standard Deviation 166.0
|
|
Safety Run-in and Randomized Cohorts: Magrolimab Concentration Versus Time
Day 169: Predose
|
480 μg/mL
Standard Deviation 95.8
|
295 μg/mL
Standard Deviation 128.0
|
SECONDARY outcome
Timeframe: Up to 36 weeksPopulation: Participants in the Immunogenicity Analysis Set with available data were analyzed. Immunogenicity Analysis Set included all participants who received any amount of magrolimab and had at least 1 evaluable anti-drug antibody test result.
Outcome measures
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=10 Participants
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=37 Participants
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|
|
Safety Run-in and Randomized Cohorts: Percentage of Participants With Antidrug Antibodies (ADA) to Magrolimab
|
0.0 percentage of participants
|
5.4 percentage of participants
|
Adverse Events
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
Serious events: 5 serious events
Other events: 10 other events
Deaths: 6 deaths
Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI
Serious events: 16 serious events
Other events: 43 other events
Deaths: 2 deaths
Randomized Cohort: Bevacizumab + FOLFIRI
Serious events: 6 serious events
Other events: 19 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=10 participants at risk
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=44 participants at risk
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=21 participants at risk
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.5%
2/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.5%
2/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Enteritis
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Rectourethral fistula
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Covid-19
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Perirectal abscess
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.5%
2/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Tooth abscess
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
Liver function test abnormal
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
Other adverse events
| Measure |
Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=10 participants at risk
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 36 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI
n=44 participants at risk
Participants received magrolimab + bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle.
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
Randomized Cohort: Bevacizumab + FOLFIRI
n=21 participants at risk
Participants received bevacizumab + FOLFIRI intravenous infusions for 34 weeks as mentioned below:
* Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle.
* FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours Q2W (Days 1 and 15) of every 28-day cycle.
|
|---|---|---|---|
|
General disorders
Mucosal inflammation
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
60.0%
6/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
56.8%
25/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
19.0%
4/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
3/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
29.5%
13/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
23.8%
5/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.1%
4/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Eye disorders
Dry eye
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Eye disorders
Lacrimation increased
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Eye disorders
Vitreous floaters
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
22.7%
10/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
19.0%
4/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
20.5%
9/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
23.8%
5/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
6/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
56.8%
25/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
52.4%
11/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.1%
4/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
90.0%
9/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
52.3%
23/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
47.6%
10/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
5/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
36.4%
16/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
4/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
31.8%
14/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
23.8%
5/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
General disorders
Asthenia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
20.5%
9/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
14.3%
3/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
General disorders
Chest pain
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
General disorders
Chills
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
13.6%
6/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
General disorders
Fatigue
|
80.0%
8/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
43.2%
19/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
28.6%
6/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
General disorders
Influenza like illness
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
General disorders
Malaise
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
General disorders
Pyrexia
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
15.9%
7/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
19.0%
4/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Hepatobiliary disorders
Subcapsular hepatic haematoma
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Covid-19
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.5%
2/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Gingivitis
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
40.0%
4/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.1%
4/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Stoma complication
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.5%
2/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
13.6%
6/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
Neutrophil count decreased
|
40.0%
4/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
22.7%
10/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
23.8%
5/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
Platelet count decreased
|
30.0%
3/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
15.9%
7/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
Weight decreased
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
13.6%
6/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
19.0%
4/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
Weight increased
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Investigations
White blood cell count decreased
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
20.5%
9/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
4/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
34.1%
15/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
28.6%
6/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
13.6%
6/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
11.4%
5/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.5%
2/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.5%
2/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
13.6%
6/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.1%
4/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
34.1%
15/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.5%
2/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.1%
4/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.5%
2/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
13.6%
6/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
15.9%
7/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
14.3%
3/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
11.4%
5/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
23.8%
5/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
13.6%
6/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
23.8%
5/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
14.3%
3/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.1%
4/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
20.5%
9/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
33.3%
7/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
6.8%
3/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
20.0%
2/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.1%
4/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.5%
2/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
2.3%
1/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Vascular disorders
Flushing
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
0.00%
0/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
9.1%
4/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
14.3%
3/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.5%
2/44 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
4.8%
1/21 • All-cause mortality: Up to 83.4 weeks; Adverse events: Up to 36 weeks plus 30 days
All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER