Trial Outcomes & Findings for A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT05613088)
NCT ID: NCT05613088
Last Updated: 2026-04-30
Results Overview
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)
Results posted on
2026-04-30
Participant Flow
Enrollment was stopped and no participants were enrolled into Arm A (MORAb-202 at 33 mg/m\^2)
Participant milestones
| Measure |
MORAb-202
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
Investigator's Choice (IC) Chemotherapy
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
|---|---|---|
|
Pre-Treatment
STARTED
|
70
|
36
|
|
Pre-Treatment
COMPLETED
|
70
|
34
|
|
Pre-Treatment
NOT COMPLETED
|
0
|
2
|
|
Treatment
STARTED
|
70
|
34
|
|
Treatment
COMPLETED
|
0
|
0
|
|
Treatment
NOT COMPLETED
|
70
|
34
|
Reasons for withdrawal
| Measure |
MORAb-202
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
Investigator's Choice (IC) Chemotherapy
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
|---|---|---|
|
Treatment
Ongoing Study Treatment
|
9
|
2
|
|
Treatment
Adverse Event
|
3
|
1
|
|
Treatment
Other Reasons
|
0
|
1
|
|
Treatment
Progressive Disease
|
58
|
26
|
|
Treatment
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
Investigator's Choice (IC) Chemotherapy
n=36 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 Years
STANDARD_DEVIATION 9.15 • n=14 Participants
|
61.3 Years
STANDARD_DEVIATION 12.16 • n=34 Participants
|
59.3 Years
STANDARD_DEVIATION 10.31 • n=69 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=14 Participants
|
36 Participants
n=34 Participants
|
106 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=14 Participants
|
7 Participants
n=34 Participants
|
19 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=14 Participants
|
29 Participants
n=34 Participants
|
86 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=14 Participants
|
11 Participants
n=34 Participants
|
28 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=14 Participants
|
24 Participants
n=34 Participants
|
74 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)Population: All randomized participants
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=36 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
|
13.9 Percent of participants
Interval 4.7 to 29.5
|
20.0 Percent of participants
Interval 11.4 to 31.3
|
PRIMARY outcome
Timeframe: From first dose of study medication up to 6 monthsPopulation: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=34 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)Population: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=34 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
32 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)Population: All treated participants
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=34 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
10 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)Population: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=34 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Number of Participants With AEs Leading to Discontinuation
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)Population: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=34 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Number of Participants With Treatment-Related AEs
|
29 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)Population: All treated participants
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=34 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Number of Participants With Treatment-Related SAEs
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)Population: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. AEs of special interest include: Infusion-related reactions, Interstitial lung disease (ILD) and Pneumonitis
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=34 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Number of Participants With AEs of Special Interest (AESIs)
Interstitial lung disease (ILD)
|
0 Participants
|
2 Participants
|
|
Number of Participants With AEs of Special Interest (AESIs)
Pneumonitis
|
0 Participants
|
13 Participants
|
|
Number of Participants With AEs of Special Interest (AESIs)
Infusion-related reactions
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study medication until death due to any cause (up to 70 weeks)Population: All treated participants
Number of participants who died during the study.
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=34 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Number of Participants Who Died
|
6 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)Population: All treated participants
Number of participants experiencing clinical abnormalities in laboratory testing including hematology, chemistry, liver function, and renal function. Laboratory findings are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=34 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Number of Participants With Grade 3-4 Laboratory Abnormalities
Grade 3: Lymphocytes (absolute)
|
0 Participants
|
3 Participants
|
|
Number of Participants With Grade 3-4 Laboratory Abnormalities
Grade 3: Absolute neutrophil count
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)Population: All randomized participants
Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on investigator assessments (using RECIST v1.1) divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the 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, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Clopper and Pearson estimates of duration of response
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=36 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment
|
69.4 Percent of participants
Interval 51.9 to 83.7
|
80.0 Percent of participants
Interval 68.7 to 88.6
|
SECONDARY outcome
Timeframe: From the date of first dose to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 70 weeks)Population: All confirmed responders
Duration of Response (DoR) is defined as the time between the date of first documented response (CR or PR) confirmed, to the date of the first objectively documented tumor progression by investigator (per RECIST v1.1) or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the 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, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=5 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=14 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment
|
5.55 Months
Interval 2.37 to
Insufficient number of events for upper limit
|
4.42 Months
Interval 2.5 to
Insufficient number of events for upper limit
|
SECONDARY outcome
Timeframe: From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)Population: All randomized participants
Progression-free Survival (PFS) is defined as the time between the date of randomization and the first date of documented progression, per investigator assessments (using RECIST v1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the 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, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of progression-free survival
Outcome measures
| Measure |
Investigator's Choice (IC) Chemotherapy
n=36 Participants
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
MORAb-202
n=70 Participants
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
|---|---|---|
|
Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment
|
4.40 Months
Interval 3.98 to 6.67
|
4.01 Months
Interval 2.79 to 4.67
|
Adverse Events
MORAb-202
Serious events: 22 serious events
Other events: 61 other events
Deaths: 34 deaths
Investigator's Choice (IC) Chemotherapy
Serious events: 11 serious events
Other events: 31 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
MORAb-202
n=70 participants at risk
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
Investigator's Choice (IC) Chemotherapy
n=34 participants at risk
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Cardiac disorders
Coronary artery occlusion
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
3/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Ileus
|
2.9%
2/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
7.1%
5/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.3%
3/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
General disorders
Oedema peripheral
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
General disorders
Pain
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
General disorders
Pyrexia
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Infections and infestations
Abdominal abscess
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Infections and infestations
Renal abscess
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.9%
2/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
Other adverse events
| Measure |
MORAb-202
n=70 participants at risk
Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years
|
Investigator's Choice (IC) Chemotherapy
n=34 participants at risk
Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
10/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
23.5%
8/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.6%
6/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
7/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
29.4%
10/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.4%
15/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
2/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Ascites
|
8.6%
6/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Constipation
|
24.3%
17/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
26.5%
9/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
8/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
11.8%
4/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Nausea
|
24.3%
17/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
44.1%
15/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
17.6%
6/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
9/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
14.7%
5/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
General disorders
Asthenia
|
17.1%
12/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
17.6%
6/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
General disorders
Fatigue
|
15.7%
11/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
20.6%
7/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
11.8%
4/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
General disorders
Oedema peripheral
|
7.1%
5/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
General disorders
Pyrexia
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
11.8%
4/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
4/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Investigations
Alanine aminotransferase increased
|
8.6%
6/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
6/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Investigations
Blood albumin decreased
|
2.9%
2/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Investigations
Blood magnesium decreased
|
2.9%
2/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Investigations
Neutrophil count decreased
|
2.9%
2/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
26.5%
9/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Investigations
Platelet count decreased
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Investigations
Weight decreased
|
4.3%
3/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Investigations
White blood cell count decreased
|
2.9%
2/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.6%
6/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
17.6%
6/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.6%
6/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.9%
2/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
11.8%
4/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.9%
2/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
11.8%
4/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.9%
9/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
4/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.4%
8/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Nervous system disorders
Dizziness
|
4.3%
3/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Nervous system disorders
Headache
|
20.0%
14/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
17.6%
6/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
5/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Psychiatric disorders
Insomnia
|
4.3%
3/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
5/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
2.9%
1/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
3/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
18.6%
13/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
0.00%
0/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
3/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
14.7%
5/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.4%
1/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
5/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Vascular disorders
Hypertension
|
2.9%
2/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
8.8%
3/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/70 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
5.9%
2/34 • Participants were assessed for all-cause mortality from randomization until death or data cut off date 29Apr2025 (up to approximately 70 weeks). SAEs and Other AEs from first dose of study medication until 29Apr2025 (up to approximately 70 weeks).
All-cause Mortality refers to all randomized participants. SAEs and other AEs refers to all the participants who were treated with study medicine.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER