Trial Outcomes & Findings for Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (NCT NCT04644237)
NCT ID: NCT04644237
Last Updated: 2025-11-21
Results Overview
Confirmed objective response rate (ORR), defined as the proportion of participants with complete response (CR) or partial response (PR), was assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
152 participants
Primary outcome timeframe
9 months after the last participant is randomized to data cut off, up to approximately 21 months
Results posted on
2025-11-21
Participant Flow
A total of 152 participants were enrolled and treated at clinic centers in North America, Europe, and Asia-Pacific.
Participant milestones
| Measure |
Trastuzumab Deruxtecan 5.4 mg/kg
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 6.4 mg/kg
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
50
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
102
|
50
|
Reasons for withdrawal
| Measure |
Trastuzumab Deruxtecan 5.4 mg/kg
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 6.4 mg/kg
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Overall Study
Death
|
4
|
2
|
|
Overall Study
Adverse Event
|
18
|
19
|
|
Overall Study
Progressive Disease
|
61
|
23
|
|
Overall Study
Clinical Progression
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Physician Decision
|
4
|
0
|
|
Overall Study
Other
|
6
|
3
|
|
Overall Study
Randomized but not Treated
|
1
|
0
|
Baseline Characteristics
Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Trastuzumab Deruxtecan 5.4 mg/kg
n=102 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=39 Participants
|
35 Participants
n=29 Participants
|
97 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=39 Participants
|
15 Participants
n=29 Participants
|
55 Participants
n=60 Participants
|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 11.59 • n=39 Participants
|
59.5 years
STANDARD_DEVIATION 12.14 • n=29 Participants
|
59.7 years
STANDARD_DEVIATION 11.73 • n=60 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=39 Participants
|
34 Participants
n=29 Participants
|
99 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=39 Participants
|
16 Participants
n=29 Participants
|
53 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
65 Participants
n=39 Participants
|
31 Participants
n=29 Participants
|
96 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=39 Participants
|
5 Participants
n=29 Participants
|
28 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=39 Participants
|
12 Participants
n=29 Participants
|
26 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 9 months after the last participant is randomized to data cut off, up to approximately 21 monthsPopulation: Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
Confirmed objective response rate (ORR), defined as the proportion of participants with complete response (CR) or partial response (PR), was assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=102 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Percentage of Participants With Confirmed Objective Response Rate by Blinded Independent Central Review Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
|
56.0 percentage of participants
Interval 41.3 to 70.0
|
50.0 percentage of participants
Interval 39.9 to 60.1
|
SECONDARY outcome
Timeframe: 9 months after the last participant is randomized or later to data cut off, up to approximately 35 monthsPopulation: Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
Confirmed objective response rate (ORR), defined as the percentage of participants with complete response (CR) or partial response (PR), will be assessed by the Investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=102 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Percentage of Participants With Confirmed Objective Response Rate by Investigator Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung CancerTumors
|
56.0 Percentage of participants
Interval 41.3 to 70.0
|
46.1 Percentage of participants
Interval 36.2 to 56.2
|
SECONDARY outcome
Timeframe: 9 months after the last participant is randomized or later to data cut off, up to approximately 35 monthsPopulation: Full Analysis Set includes all subjects for whom study treatment was assigned by randomization. From the Full Analysis Set, 47 participants had a confirmed CR or PR in T-DXd 5.4 mg/kg arm, and 28 participants in T-DXd 6.4 mg/kg arm
Duration of response (DoR) is defined as the time from the initial response (complete response \[CR\] or partial response \[PR\]) until documented tumor progression or death from any cause. DoR is only defined for participants who achieved confirmed CR or PR. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=28 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=47 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Duration of Response Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
|
12.9 months
Interval 6.9 to 15.4
|
11.1 months
Interval 8.3 to 15.5
|
SECONDARY outcome
Timeframe: 9 months after the last participant is randomized or later to data cut off, up to approximately 35 monthsPopulation: Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
Disease control rate (DCR) is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=102 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Disease Control Rate Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
|
88.0 Percentage of participants
Interval 75.7 to 95.5
|
90.2 Percentage of participants
Interval 82.7 to 95.2
|
SECONDARY outcome
Timeframe: 9 months after the last participant is randomized or later to data cut off, up to approximately 35 monthsPopulation: Full Analysis Set includes all subjects for whom study treatment was assigned by randomization
Progression-free survival (PFS) is defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on blinded independent central review (BICR) and investigator assessment.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=102 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Progression-free Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer
|
9.5 months
Interval 6.5 to 15.1
|
9.7 months
Interval 8.2 to 11.3
|
SECONDARY outcome
Timeframe: 9 months after the last participant is randomized or later to data cut off, up to approximately 35 monthsPopulation: Full Analysis Set
Overall survival (OS) is defined as the time from date of randomization until death from any cause.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=102 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Overall Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer Tumors
|
17.9 months
Interval 13.8 to
Not estimable due to insufficient number of participants with events
|
19.0 months
Interval 14.7 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 9 months after the last participant is randomized or later to data cut off, up to approximately 35 monthsPopulation: Safety Analysis Set
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=102 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
The Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer Tumors
|
50 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; Cycle 2 Day 1, and Cycle 3 Day 1: pre- and post-dose; Cycle 1 Day 8: 7 days post-dose; Cycle 1 Day 15: 14 days post-dose; Cycle 4 Day 1 and Cycle 6 Day 1: pre-dose (each cycle is 21 days)Population: The PK Analysis Set included all randomized subjects who received at least one dose of study drug and had any measurable post-dose serum concentrations of T-DXd, total anti-HER2 antibody, and DXd.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=101 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
DXd (Metabolite Active Metabolite MAAA-1181a)
|
.018 µg/mL
Standard Deviation .008
|
.015 µg/mL
Standard Deviation .007
|
|
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
Trastuzumab Deruxtecan
|
196 µg/mL
Standard Deviation 184
|
148 µg/mL
Standard Deviation 69.5
|
|
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
Total Anti-HER2 Antibody
|
179 µg/mL
Standard Deviation 194
|
138 µg/mL
Standard Deviation 57.8
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; Cycle 2 Day 1, and Cycle 3 Day 1: pre- and post-dose; Cycle 1 Day 8: 7 days post-dose; Cycle 1 Day 15: 14 days post-dose; Cycle 4 Day 1 and Cycle 6 Day 1: pre-dose (each cycle is 21 days)Population: The PK Analysis Set included all randomized subjects who received at least one dose of study drug and had any measurable post-dose serum concentrations of T-DXd, total anti-HER2 antibody, and DXd.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=101 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Pharmacokinetic Parameter Minimum Observed Concentration (Ctrough) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
Total Anti-HER2 Antibody
|
7.16 µg/mL
Standard Deviation 5.00
|
6.39 µg/mL
Standard Deviation 10.7
|
|
Pharmacokinetic Parameter Minimum Observed Concentration (Ctrough) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
DXd (Metabolite Active Metabolite MAAA-1181a)
|
.0003 µg/mL
Standard Deviation .0002
|
.0003 µg/mL
Standard Deviation .0003
|
|
Pharmacokinetic Parameter Minimum Observed Concentration (Ctrough) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
Trastuzumab Deruxtecan
|
5.84 µg/mL
Standard Deviation 3.48
|
5.47 µg/mL
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; Cycle 2 Day 1, and Cycle 3 Day 1: pre- and post-dose; Cycle 1 Day 8: 7 days post-dose; Cycle 1 Day 15: 14 days post-dose; Cycle 4 Day 1 and Cycle 6 Day 1: pre-dose (each cycle is 21 days)Population: The PK Analysis Set included all randomized subjects who received at least one dose of study drug and had any measurable post-dose serum concentrations of T-DXd, total anti-HER2 antibody, and DXd.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=101 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Pharmacokinetic Parameter Area Under the Serum Concentration-Time Curve (AUC) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
Trastuzumab Deruxtecan
|
793 µg × d/mL
Standard Deviation 210
|
658 µg × d/mL
Standard Deviation 185
|
|
Pharmacokinetic Parameter Area Under the Serum Concentration-Time Curve (AUC) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
Total Anti-HER2 Antibody
|
829 µg × d/mL
Standard Deviation 261
|
697 µg × d/mL
Standard Deviation 208
|
|
Pharmacokinetic Parameter Area Under the Serum Concentration-Time Curve (AUC) for Trastuzumab Deruxtecan, Total Anti-HER2 Antibody, and Active Metabolite MAAA-1181a
DXd (Metabolite Active Metabolite MAAA-1181a)
|
.059 µg × d/mL
Standard Deviation .017
|
.050 µg × d/mL
Standard Deviation .022
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 2 and 4, and then every 4 cycles (each cycle is 21 days), up to Cycle 28 and End of Treatment.Population: The Immunogenicity Analysis Set included all subjects who received at least one dose of the study drug and who had at least one baseline or post-baseline immunogenicity assessment
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=101 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Number of Participants With Anti-Drug Antibodies (ADA) Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer Tumors
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At baseline and at end of treatment 40-day follow-up visitPopulation: Full Analysis Set
The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms. The QLQ-LC13 is a 13-item questionnaire designed to assess lung cancer-related symptoms and treatment side effects. The scales ranges from 1=not at all to 4=very much. The summation of scores range from 0 to 100, where higher scores represent increasing symptoms levels. scales.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=102 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores
QLQ-C30: Change from Baseline 40-Day Follow-up
|
15.63 score on scale
Standard Deviation 31.947
|
-1.11 score on scale
Standard Deviation 17.780
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and EORTC Quality of Life Questionnaire for Lung Cancer Trials (QLQ-LC13) Scores
QLQ-LC13: Change from Baseline 40-Day Follow-up
|
-29.17 score on scale
Standard Deviation 27.817
|
-2.38 score on scale
Standard Deviation 24.335
|
SECONDARY outcome
Timeframe: At baseline and at end of treatment 40-day follow-up visitPopulation: Full Analysis Set
The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms.
Outcome measures
| Measure |
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 Participants
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 5.4 mg/kg
n=102 Participants
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Time to Deterioration in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Scores
|
9.3 months
Interval 2.5 to
Not estimable due to insufficient number of participants with events
|
8.6 months
Interval 4.9 to 11.4
|
Adverse Events
Trastuzumab Deruxtecan 5.4 mg/kg
Serious events: 42 serious events
Other events: 101 other events
Deaths: 52 deaths
Trastuzumab Deruxtecan 6.4 mg/kg
Serious events: 26 serious events
Other events: 50 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Trastuzumab Deruxtecan 5.4 mg/kg
n=101 participants at risk
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 participants at risk
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Cardiac disorders
Myocarditis
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Cardiac disorders
Acute myocardial infarction
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Cardiac disorders
Pericardial effusion
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Endocrine disorders
Hypothyroidism
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Eye disorders
Optic nerve disorder
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.99%
1/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Ileus
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
General disorders
Fatigue
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
General disorders
General physical health deterioration
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
General disorders
Pyrexia
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
General disorders
Malaise
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
COVID-19
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
COVID-19 pneumonia
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
0.99%
1/101 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
Meningitis
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Troponin I increased
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Neutrophil count decreased
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Platelet count decreased
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
General physical condition abnormal
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Nervous system disorders
Intracranial tumour haemorrhage
|
0.99%
1/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Nervous system disorders
Cerebrovascular accident
|
0.99%
1/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Nervous system disorders
Intracranial pressure increased
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Nervous system disorders
Neurological symptom
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
4/101 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Eye disorders
Diplopia
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
Pneumococcal sepsis
|
0.99%
1/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Blood creatine phosphokinase increased
|
0.99%
1/101 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
0.00%
0/50 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
Other adverse events
| Measure |
Trastuzumab Deruxtecan 5.4 mg/kg
n=101 participants at risk
Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
Trastuzumab Deruxtecan 6.4 mg/kg
n=50 participants at risk
Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
40.6%
41/101 • Number of events 113 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
48.0%
24/50 • Number of events 81 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.9%
13/101 • Number of events 35 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
16.0%
8/50 • Number of events 29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
68.3%
69/101 • Number of events 166 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
82.0%
41/50 • Number of events 85 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
37.6%
38/101 • Number of events 56 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
34.0%
17/50 • Number of events 26 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
30.7%
31/101 • Number of events 63 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
44.0%
22/50 • Number of events 38 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
24.8%
25/101 • Number of events 42 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
36.0%
18/50 • Number of events 32 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Stomatitis
|
14.9%
15/101 • Number of events 22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
14.0%
7/50 • Number of events 12 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
7.9%
8/101 • Number of events 8 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
7/101 • Number of events 10 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
14.0%
7/50 • Number of events 9 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
6/101 • Number of events 6 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.0%
3/101 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/101 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
General disorders
Asthenia
|
18.8%
19/101 • Number of events 46 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
26.0%
13/50 • Number of events 42 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
General disorders
Fatigue
|
15.8%
16/101 • Number of events 18 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
14.0%
7/50 • Number of events 16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
General disorders
Malaise
|
15.8%
16/101 • Number of events 43 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
10.0%
5/50 • Number of events 8 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
General disorders
Pyrexia
|
11.9%
12/101 • Number of events 18 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
16.0%
8/50 • Number of events 10 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
General disorders
Oedema peripheral
|
4.0%
4/101 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
General disorders
Chest pain
|
3.0%
3/101 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
8.0%
4/50 • Number of events 6 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
COVID-19
|
16.8%
17/101 • Number of events 21 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
18.0%
9/50 • Number of events 11 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
Paronychia
|
7.9%
8/101 • Number of events 11 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
6.9%
7/101 • Number of events 9 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
14.0%
7/50 • Number of events 10 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
4.0%
4/101 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
10.0%
5/50 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Neutrophil count decreased
|
31.7%
32/101 • Number of events 171 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
40.0%
20/50 • Number of events 79 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Infections and infestations
White blood cell count decreased
|
25.7%
26/101 • Number of events 118 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
32.0%
16/50 • Number of events 68 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Platelet count decreased
|
25.7%
26/101 • Number of events 118 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
32.0%
16/50 • Number of events 68 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Aspartate aminotransferase increased
|
20.8%
21/101 • Number of events 36 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
14.0%
7/50 • Number of events 17 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Alanine aminotransferase increased
|
13.9%
14/101 • Number of events 28 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
16.0%
8/50 • Number of events 13 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Weight decreased
|
16.8%
17/101 • Number of events 32 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
14.0%
7/50 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Blood creatinine increased
|
5.9%
6/101 • Number of events 8 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
8.0%
4/50 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Investigations
Blood bilirubin increased
|
3.0%
3/101 • Number of events 12 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
18.0%
9/50 • Number of events 13 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.6%
41/101 • Number of events 64 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
50.0%
25/50 • Number of events 49 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.9%
13/101 • Number of events 26 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.9%
6/101 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
9/101 • Number of events 13 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
8.0%
4/50 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
6/101 • Number of events 10 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
4/101 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
12.9%
13/101 • Number of events 17 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
2.0%
1/50 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Nervous system disorders
Headache
|
6.9%
7/101 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
8.0%
4/50 • Number of events 6 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.9%
10/101 • Number of events 11 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
14.0%
7/50 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
7.9%
8/101 • Number of events 9 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
14.0%
7/50 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.9%
7/101 • Number of events 8 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
18.0%
9/50 • Number of events 11 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.9%
7/101 • Number of events 9 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
18.0%
9/50 • Number of events 11 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.8%
22/101 • Number of events 26 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
34.0%
17/50 • Number of events 21 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
2/101 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.9%
7/101 • Number of events 15 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
4.0%
2/50 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.0%
4/101 • Number of events 17 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.0%
3/101 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
6.0%
3/50 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
5/101 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
8.0%
4/50 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 35 months
A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened after initiating study treatment up until 47 days after the last dose of the study treatment. All-Cause Mortality was assessed in the Full Analysis Set, all adverse events were assessed in the Safety Analysis Set
|
Additional Information
Contact for Clinical Trial Information
Daiichi Sanyko, Inc
Phone: 908-992-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place