Trial Outcomes & Findings for Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies (NCT NCT03126110)
NCT ID: NCT03126110
Last Updated: 2025-08-14
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
145 participants
Primary outcome timeframe
up to approximately 27.4 months
Results posted on
2025-08-14
Participant Flow
Participants were enrolled at 32 study centers in Australia, Belgium, Spain, and the United States.
Participant milestones
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
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Phase 1
STARTED
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4
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4
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5
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5
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4
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8
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3
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6
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0
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0
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0
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0
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Phase 1
COMPLETED
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0
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1
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1
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0
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0
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0
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0
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0
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Phase 1
NOT COMPLETED
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4
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3
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5
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4
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5
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4
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3
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4
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8
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3
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6
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0
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0
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0
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0
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0
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0
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Phase 2
STARTED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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8
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16
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46
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18
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4
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2
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Phase 2
COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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12
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2
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0
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0
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Phase 2
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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8
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16
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34
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16
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4
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2
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Reasons for withdrawal
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Phase 1
Death
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2
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2
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4
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3
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4
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4
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3
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4
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5
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2
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6
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0
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0
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0
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0
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0
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0
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Phase 1
Lost to Follow-up
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0
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1
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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Phase 1
Withdrawal by Subject
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1
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0
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0
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1
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1
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0
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0
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0
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2
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1
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0
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0
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0
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0
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0
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0
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0
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Phase 1
Safety follow-up no longer necessary
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Phase 1
Survival follow-up no longer necessary
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Phase 2
Study terminated by the sponsor
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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4
|
0
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0
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0
|
|
Phase 2
Withdrawal by Subject
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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3
|
3
|
2
|
1
|
0
|
|
Phase 2
Lost to Follow-up
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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1
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1
|
2
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0
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0
|
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Phase 2
Death
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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6
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12
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25
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11
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3
|
2
|
|
Phase 2
Progressive Disease
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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Phase 2
Started new treatment
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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Baseline Characteristics
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
Baseline characteristics by cohort
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
n=6 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
n=8 Participants
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
n=16 Participants
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
n=46 Participants
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
n=18 Participants
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
n=4 Participants
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
n=2 Participants
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Age, Continuous
|
51.3 Years
STANDARD_DEVIATION 7.37 • n=5 Participants
|
59.8 Years
STANDARD_DEVIATION 14.03 • n=7 Participants
|
48.0 Years
STANDARD_DEVIATION 18.23 • n=5 Participants
|
62.3 Years
STANDARD_DEVIATION 7.04 • n=4 Participants
|
60.8 Years
STANDARD_DEVIATION 12.40 • n=21 Participants
|
62.5 Years
STANDARD_DEVIATION 16.36 • n=10 Participants
|
63.0 Years
STANDARD_DEVIATION 9.90 • n=115 Participants
|
61.5 Years
STANDARD_DEVIATION 11.73 • n=24 Participants
|
61.8 Years
STANDARD_DEVIATION 7.70 • n=42 Participants
|
67.7 Years
STANDARD_DEVIATION 4.16 • n=42 Participants
|
58.5 Years
STANDARD_DEVIATION 11.24 • n=42 Participants
|
69.1 Years
STANDARD_DEVIATION 9.46 • n=42 Participants
|
59.1 Years
STANDARD_DEVIATION 10.48 • n=36 Participants
|
60.5 Years
STANDARD_DEVIATION 9.46 • n=36 Participants
|
48.6 Years
STANDARD_DEVIATION 9.43 • n=24 Participants
|
54.3 Years
STANDARD_DEVIATION 9.29 • n=135 Participants
|
42.0 Years
STANDARD_DEVIATION 16.97 • n=136 Participants
|
58.56 Years
STANDARD_DEVIATION 11.38 • n=44 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
18 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
68 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
38 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
77 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
8 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
43 Participants
n=36 Participants
|
17 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
134 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
45 Participants
n=36 Participants
|
16 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
128 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiin or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Other: Captured as "Other"
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Other: Zimbabwean
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
Other: Mexican
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: up to approximately 27.4 monthsPopulation: Phase 1 Full Analysis Set (FAS): all participants enrolled in Phase 1 of the study who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=6 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
4 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 Response Evaluable Population: all participants enrolled in Phase 2 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR), determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=8 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=16 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=46 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=18 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) Per RECIST v1.1
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
23.9 Percentage of Participants
|
16.7 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 Response Evaluable Population: all participants enrolled in Phase 1 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment
ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=6 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: ORR Per RECIST v1.1
|
25.0 Percentage of Participants
|
0.0 Percentage of Participants
|
20.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
12.5 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 Response Evaluable Population
ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=6 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: ORR Per Modified RECIST (mRECIST) v1.1
|
25.0 Percentage of Participants
|
0.0 Percentage of Participants
|
20.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
25.0 Percentage of Participants
|
25.0 Percentage of Participants
|
12.5 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 Response Evaluable Population
ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=8 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=16 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=46 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=18 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: ORR Per mRECIST v1.1
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
26.1 Percentage of Participants
|
16.7 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
DOR was defined as the time from the first overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=1 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=1 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Response (DOR) Per RECIST v1.1
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
573.0 Days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
—
|
—
|
876.0 Days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
281.0 Days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=11 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=3 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: DOR Per RECIST v1.1
|
—
|
—
|
NA Days
Interval 118.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
120.0 Days
Interval 113.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
DOR was defined as the time from the first unconfirmed overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first confirmed assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=1 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=1 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: DOR Per mRECIST v1.1
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
—
|
—
|
876.0 Days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=12 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=3 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: DOR Per mRECIST v1.1
|
—
|
—
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
Interval 113.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 Response Evaluable Population
DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=6 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Disease Control Rate (DCR) Per RECIST v1.1
|
25.0 Percentage of Participants
|
50.0 Percentage of Participants
|
20.0 Percentage of Participants
|
50.0 Percentage of Participants
|
0.0 Percentage of Participants
|
25.0 Percentage of Participants
|
50.0 Percentage of Participants
|
25.0 Percentage of Participants
|
50.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 Response Evaluable Population
DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=8 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=16 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=46 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=18 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: DCR Per RECIST v1.1
|
37.5 Percentage of Participants
|
56.3 Percentage of Participants
|
54.3 Percentage of Participants
|
55.6 Percentage of Participants
|
50.0 Percentage of Participants
|
50.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 Response Evaluable Population
DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=6 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: DCR Per mRECIST v1.1
|
25.0 Percentage of Participants
|
50.0 Percentage of Participants
|
20.0 Percentage of Participants
|
50.0 Percentage of Participants
|
0.0 Percentage of Participants
|
25.0 Percentage of Participants
|
50.0 Percentage of Participants
|
25.0 Percentage of Participants
|
50.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 Response Evaluable Population
DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or SD (≥49 days), determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=8 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=16 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=46 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=18 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: DCR Per mRECIST v1.1
|
37.5 Percentage of Participants
|
56.3 Percentage of Participants
|
56.5 Percentage of Participants
|
55.6 Percentage of Participants
|
50.0 Percentage of Participants
|
50.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.
Duration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=1 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Disease Control Per RECIST v1.1
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
Interval 89.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
624.0 Days
The median was not estimable because too few participants had disease progression or died.
|
76.0 Days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
167.0 Days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
668.5 Days
Interval 125.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
250.5 Days
Interval 110.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.
Duration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=3 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=9 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=25 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=10 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Disease Control Per RECIST v1.1
|
218.0 Days
Interval 106.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
109.0 Days
Interval 63.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
253.0 Days
Interval 156.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
168.0 Days
Interval 71.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
206.5 Days
Interval 118.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
109.0 Days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.
Duration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=1 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Duration of Disease Control Per mRECIST v1.1
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
76.0 Days
The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
668.5 Days
Interval 125.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
Interval 134.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 Response Evaluable Population. The confidence intervals was calculated based on the exact method for binomial distributions. Only those participants with a response of SD, CR, or PR were analyzed.
Duration of disease control (CR, PR, and SD \[≥49 days\]) was measured from the start of treatment until PD or death from any cause, if occurring sooner than progression, determined by investigator assessment of radiographic disease per RECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. \[
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=3 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=9 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=26 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=10 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=1 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Duration of Disease Control Per mRECIST v1.1
|
218.0 Days
Interval 133.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
168.0 Days
Interval 63.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
NA Days
Interval 202.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
Interval 137.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
Interval 118.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=6 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Progression-free Survival (PFS) Per RECIST v1.1
|
52.5 Days
Interval 48.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
72.0 Days
Interval 53.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
53.0 Days
Interval 9.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
64.0 Days
Interval 48.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
47.5 Days
Interval 29.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
60.0 Days
Interval 50.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
88.5 Days
Interval 44.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
41.0 Days
Interval 15.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
110.0 Days
Interval 53.0 to 276.0
|
56.0 Days
Interval 53.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
54.5 Days
Interval 21.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
According to RECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of death or the first assessment of PD, as determined by investigator assessment of objective radiographic disease assessments.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=8 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=16 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=46 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=18 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: PFS Per RECIST v1.1
|
57.0 Days
Interval 20.0 to 218.0
|
75.0 Days
Interval 45.0 to 120.0
|
115.0 Days
Interval 59.0 to 174.0
|
102.0 Days
Interval 51.0 to 225.0
|
87.0 Days
Interval 52.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
64.5 Days
Interval 20.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=6 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: PFS Per mRECIST v1.1
|
66.0 Days
Interval 48.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
NA Days
Interval 55.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
116.0 Days
Interval 64.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
88.0 Days
Interval 76.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
57.0 Days
Interval 29.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
NA Days
Interval 100.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
98.0 Days
Interval 52.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
NA Days
Interval 97.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
134.0 Days
Interval 53.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
128.0 Days
Interval 56.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
NA Days
Interval 46.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
According to mRECIST 1.1, PFS was defined as the length of time between the Baseline visit (Day 1) and the earlier of the participant's death or the first confirmed assessment of PD, as determined by investigator assessment of objective radiographic disease assessments. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase).
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=8 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=16 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=46 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=18 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: PFS Per mRECIST v1.1
|
85.0 Days
Interval 20.0 to 218.0
|
105.0 Days
Interval 63.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
235.0 Days
Interval 129.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
168.0 Days
Interval 51.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
118.0 Days
Interval 52.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
NA Days
Interval 20.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 1 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=6 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Overall Survival
|
NA Days
Interval 76.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
NA Days
Interval 55.0 to
The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died.
|
253.0 Days
Interval 77.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
100.0 Days
Interval 76.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
289.5 Days
Interval 170.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
266.5 Days
Interval 100.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
588.0 Days
Interval 424.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
200.0 Days
Interval 97.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
425.0 Days
Interval 110.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
627.0 Days
Interval 128.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
229.5 Days
Interval 46.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
SECONDARY outcome
Timeframe: up to approximately 44.7 monthsPopulation: Phase 2 FAS. Median survival time was estimated using the Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Overall survival was defined as the interval between the Baseline visit (Day 1) and the date of death due to any cause.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=8 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=16 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=46 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=18 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Overall Survival
|
290.5 Days
Interval 20.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
179.0 Days
Interval 75.0 to 404.0
|
491.0 Days
Interval 344.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
492.0 Days
Interval 92.0 to 733.0
|
485.0 Days
Interval 52.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
264.0 Days
Interval 20.0 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 27.4 monthsPopulation: Phase 2 FAS
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
Outcome measures
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=8 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=16 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=46 Participants
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=18 Participants
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 Participants
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=2 Participants
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 1.0 mg/kg + Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: : Number of Participants With Any TEAE
|
8. Participants
|
16 Participants
|
45 Participants
|
18 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Serious events: 2 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Serious events: 3 serious events
Other events: 7 other events
Deaths: 5 deaths
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 6 deaths
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Serious events: 11 serious events
Other events: 15 other events
Deaths: 12 deaths
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Serious events: 19 serious events
Other events: 43 other events
Deaths: 25 deaths
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Serious events: 10 serious events
Other events: 18 other events
Deaths: 11 deaths
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Total
Serious events: 68 serious events
Other events: 139 other events
Deaths: 98 deaths
Serious adverse events
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 participants at risk
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 participants at risk
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 participants at risk
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 participants at risk
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 participants at risk
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 participants at risk
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 participants at risk
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 participants at risk
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 participants at risk
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 participants at risk
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
n=6 participants at risk
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
n=8 participants at risk
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
n=16 participants at risk
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
n=46 participants at risk
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
n=18 participants at risk
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
n=4 participants at risk
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
n=2 participants at risk
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Total
n=145 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.8%
4/145 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Ascites
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Death
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Product Issues
Device occlusion
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Facial pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Performance status decreased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.5%
8/145 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
40.0%
2/5 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery aneurysm
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.8%
4/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Pyrexia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
Other adverse events
| Measure |
Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 participants at risk
Participants received INCAGN01876 1.0 milligrams per kilogram (mg/kg) administered intravenously (IV) every 2 weeks (Q2W) in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 participants at risk
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=5 participants at risk
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W
n=4 participants at risk
Participants received INCAGN01876 10.0 mg/kg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=5 participants at risk
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 participants at risk
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W
n=4 participants at risk
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W for a total of 2 doses as run-in, followed by nivolumab 240 mg administered IV Q2W starting at Cycle 3.
|
Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=4 participants at risk
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV every 6 weeks (Q6W).
|
Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=8 participants at risk
Participants received INCAGN01876 3.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
n=3 participants at risk
Participants received INCAGN01876 5.0 mg/kg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 1 Group D: INCAGN01876 + Nivolumab + Ipilimumab
n=6 participants at risk
Participants received INCAGN01876 1.0 mg/kg administered IV Q2W in combination with nivolumab 3 mg/kg administered IV Q2W and ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
n=8 participants at risk
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
|
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
n=16 participants at risk
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
n=46 participants at risk
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
n=18 participants at risk
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
n=4 participants at risk
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
n=2 participants at risk
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
|
Total
n=145 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
3.4%
5/145 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
6/18 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
9.0%
13/145 • Number of events 13 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
3.4%
5/145 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Allodynia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Amylase increased
|
25.0%
1/4 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
3.4%
5/145 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
3/6 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
15.2%
7/46 • Number of events 12 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
27.8%
5/18 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
17.2%
25/145 • Number of events 32 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.1%
6/145 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
40.0%
2/5 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
75.0%
3/4 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
15.2%
7/46 • Number of events 7 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
14.5%
21/145 • Number of events 22 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
4/16 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
9/145 • Number of events 11 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
40.0%
2/5 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
75.0%
6/8 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
31.2%
5/16 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
32.6%
15/46 • Number of events 22 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
27.8%
5/18 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
27.6%
40/145 • Number of events 48 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.8%
7/145 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Asthenia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
15.2%
7/46 • Number of events 10 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.1%
2/18 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
9.0%
13/145 • Number of events 17 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
4/16 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.0%
16/145 • Number of events 16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Bladder irritation
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.8%
7/145 • Number of events 10 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Eye disorders
Cataract
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.1%
2/18 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Cestode infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Chest pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Chills
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Clostridium test positive
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
17.4%
8/46 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.1%
2/18 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
14.5%
21/145 • Number of events 22 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
37.5%
3/8 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
37.5%
3/8 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
26.1%
12/46 • Number of events 14 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.1%
2/18 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.6%
27/145 • Number of events 31 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
3/6 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
43.8%
7/16 • Number of events 7 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.6%
24/145 • Number of events 24 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
3.4%
5/145 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
37.5%
6/16 • Number of events 7 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
17.4%
8/46 • Number of events 11 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
44.4%
8/18 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.6%
27/145 • Number of events 31 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
40.0%
2/5 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
2/6 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
9.0%
13/145 • Number of events 14 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.8%
7/145 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
3.4%
5/145 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
8.7%
4/46 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
7.6%
11/145 • Number of events 11 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
31.2%
5/16 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
10.9%
5/46 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
15.9%
23/145 • Number of events 23 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.8%
4/145 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.1%
2/18 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
3.4%
5/145 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
8.7%
4/46 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
9.0%
13/145 • Number of events 16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Heart rate increased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Helminthic infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.1%
2/18 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.1%
6/145 • Number of events 7 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
40.0%
2/5 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.8%
4/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Immune system disorders
Hypersensitivity
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
8.7%
4/46 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
3/18 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.5%
8/145 • Number of events 9 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.8%
4/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
15.2%
7/46 • Number of events 9 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
7.6%
11/145 • Number of events 13 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
3.4%
5/145 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.8%
7/145 • Number of events 7 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.1%
6/145 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Inadequate analgesia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Infected cyst
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.8%
7/145 • Number of events 7 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Lipase increased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 11 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 11 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Malaise
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Medical device site pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
40.0%
2/5 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.8%
4/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.5%
8/145 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.8%
4/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.8%
7/145 • Number of events 11 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
4/8 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
66.7%
2/3 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
37.5%
3/8 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
37.5%
6/16 • Number of events 7 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
15.2%
7/46 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
27.8%
5/18 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
100.0%
2/2 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
24.1%
35/145 • Number of events 40 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.8%
4/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.8%
4/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.8%
4/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Oedema
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.1%
2/18 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.7%
17/145 • Number of events 17 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Omphalitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
3.4%
5/145 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
3.4%
5/145 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.5%
8/145 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.5%
3/46 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.1%
6/145 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.5%
8/145 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Penile infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
13.0%
6/46 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.5%
8/145 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
15.2%
7/46 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
10.3%
15/145 • Number of events 17 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Protein total decreased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
40.0%
2/5 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
60.0%
3/5 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
37.5%
3/8 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
37.5%
3/8 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
19.6%
9/46 • Number of events 9 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
38.9%
7/18 • Number of events 7 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
24.8%
36/145 • Number of events 41 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
60.0%
3/5 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
13.0%
6/46 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
15.2%
22/145 • Number of events 26 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.1%
6/145 • Number of events 7 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Eye disorders
Retinal tear
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
3.4%
5/145 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Troponin I increased
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
16.7%
1/6 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
33.3%
1/3 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
13.0%
6/46 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
9.0%
13/145 • Number of events 17 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
2/16 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
1/16 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
20.0%
1/5 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
2/8 • Number of events 7 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
22.2%
4/18 • Number of events 6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
6.2%
9/145 • Number of events 19 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
1.4%
2/145 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
4.3%
2/46 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
5.6%
1/18 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.2%
1/46 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
2.1%
3/145 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
2/4 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
4/8 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
4/16 • Number of events 4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
10.9%
5/46 • Number of events 8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.1%
2/18 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
50.0%
1/2 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
14.5%
21/145 • Number of events 26 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/16 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/46 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/18 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.69%
1/145 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
|
Investigations
Weight decreased
|
25.0%
1/4 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
12.5%
1/8 • Number of events 1 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/6 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/8 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
18.8%
3/16 • Number of events 3 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
8.7%
4/46 • Number of events 5 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
11.1%
2/18 • Number of events 2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/4 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
0.00%
0/2 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
7.6%
11/145 • Number of events 12 • up to approximately 27.4 months
Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study medication, were monitored for at least 60 days after the last dose of study treatment or until the start of new anticancer therapy, whichever occurred first (up to 27.4 months). All-Cause Mortality was monitored for the duration of the study (up to 44.7 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER