Trial Outcomes & Findings for Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008) (NCT NCT05224141)
NCT ID: NCT05224141
Last Updated: 2025-07-08
Results Overview
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
460 participants
Primary outcome timeframe
Up to approximately 25 months
Results posted on
2025-07-08
Participant Flow
Participant milestones
| Measure |
Pembrolizumab/Vibostolimab
Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
Atezolizumab
Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
230
|
|
Overall Study
Treated
|
229
|
229
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
230
|
230
|
Reasons for withdrawal
| Measure |
Pembrolizumab/Vibostolimab
Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
Atezolizumab
Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
|---|---|---|
|
Overall Study
Ongoing
|
75
|
88
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Death
|
153
|
138
|
Baseline Characteristics
Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)
Baseline characteristics by cohort
| Measure |
Pembrolizumab/Vibostolimab
n=230 Participants
Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
Atezolizumab
n=230 Participants
Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
Total
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
63.9 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
63.7 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
213 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
78 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline
ECOG= 0
|
77 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline
ECOG= 1
|
153 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Lactate Dehydrogenase (LDH) Status at Baseline
≤Upper Limit of Normal (ULN)
|
92 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Lactate Dehydrogenase (LDH) Status at Baseline
>Upper Limit of Normal (ULN)
|
138 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Presence of Liver Metastases at Baseline
Yes
|
93 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Presence of Liver Metastases at Baseline
No
|
137 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Presence of Brain Metastases at Baseline
Yes
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Presence of Brain Metastases at Baseline
No
|
215 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
430 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 25 monthsPopulation: Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.
Outcome measures
| Measure |
Pembrolizumab/Vibostolimab
n=230 Participants
Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
Atezolizumab
n=230 Participants
Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
|---|---|---|
|
Overall Survival (OS)
|
11.5 Months
Interval 9.8 to 12.6
|
12.9 Months
Interval 11.6 to 14.8
|
SECONDARY outcome
Timeframe: Up to approximately 25 monthsPopulation: Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method; participants who did not experience a PFS event were censored at the last disease assessment, or the last assessment before new anticancer treatment if new treatment was initiated. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.
Outcome measures
| Measure |
Pembrolizumab/Vibostolimab
n=230 Participants
Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
Atezolizumab
n=230 Participants
Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
5.3 Months
Interval 4.4 to 5.4
|
4.5 Months
Interval 4.4 to 5.3
|
SECONDARY outcome
Timeframe: Up to approximately 25 monthsPopulation: Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
ORR was defined as the percentage of participants in the analysis population who have a confirmed Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The ORR was calculated using the Miettinen \& Nurminen method stratified by baseline ECOG performance status (0 or 1), baseline LDH (≤ or \> upper limit of normal \[ULN\]), and baseline presence of liver metastasis (Yes or No), or brain metastasis (Yes or No).
Outcome measures
| Measure |
Pembrolizumab/Vibostolimab
n=230 Participants
Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
Atezolizumab
n=230 Participants
Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
71.7 Percentage of Participants
Interval 65.4 to 77.5
|
74.8 Percentage of Participants
Interval 68.7 to 80.3
|
SECONDARY outcome
Timeframe: Up to approximately 25 monthsPopulation: Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized and experienced a CR or PR.
For participants who demonstrated a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per RECIST 1.1, DOR was defined as the time from first documented CR or PR until progressive disease (PD) or death from any cause, whichever occurs first. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). DOR was calculated using the nonparametric Kaplan-Meier method for censored data.
Outcome measures
| Measure |
Pembrolizumab/Vibostolimab
n=165 Participants
Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
Atezolizumab
n=172 Participants
Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
|---|---|---|
|
Duration of Response (DOR)
|
4.2 Months
Interval 4.1 to 4.3
|
3.9 Months
Interval 3.4 to 4.1
|
SECONDARY outcome
Timeframe: Up to approximately 60 monthsAn AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 60 monthsAn AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 60 monthsThe EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 60 monthsThe EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 60 monthsThe EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 60 monthsThe EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 60 monthsEORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 60 monthsThe EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 60 monthsThe EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 60 monthsThe EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 60 monthsThe EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to approximately 60 monthsThe EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab/Vibostolimab
Serious events: 120 serious events
Other events: 228 other events
Deaths: 155 deaths
Atezolizumab
Serious events: 96 serious events
Other events: 222 other events
Deaths: 141 deaths
Serious adverse events
| Measure |
Pembrolizumab/Vibostolimab
n=229 participants at risk
Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
Atezolizumab
n=229 participants at risk
Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.5%
8/229 • Number of events 8 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.6%
15/229 • Number of events 16 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.7%
13/229 • Number of events 13 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
4/229 • Number of events 4 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.1%
7/229 • Number of events 7 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.6%
6/229 • Number of events 6 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.1%
7/229 • Number of events 7 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac arrest
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Dilated cardiomyopathy
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Myocarditis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Pericarditis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Tachycardia
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypophysitis
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypopituitarism
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Immune-mediated adrenal insufficiency
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Retinopathy
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal perforation
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chest pain
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Death
|
2.6%
6/229 • Number of events 6 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
General physical health deterioration
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Malaise
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Liver injury
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Amoebic dysentery
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Arthritis infective
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bacterial infection
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bronchitis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
COVID-19
|
2.2%
5/229 • Number of events 5 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Catheter site infection
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Clostridium difficile infection
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Empyema
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Encephalitis
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Encephalitis cytomegalovirus
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Gastroenteritis viral
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Infection
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Meningitis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Orchitis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
8.3%
19/229 • Number of events 20 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.4%
17/229 • Number of events 19 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia aspiration
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia viral
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pulmonary sepsis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Septic shock
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Skin infection
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Urosepsis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.2%
5/229 • Number of events 5 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral infarction
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Myasthenic syndrome
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Optic neuritis
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Anxiety
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Delirium
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Calculus urinary
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Urinary retention
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.3%
3/229 • Number of events 3 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
5/229 • Number of events 5 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.87%
2/229 • Number of events 2 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Aneurysm ruptured
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Superior vena cava occlusion
|
0.00%
0/229 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.44%
1/229 • Number of events 1 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab/Vibostolimab
n=229 participants at risk
Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
Atezolizumab
n=229 participants at risk
Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
67.2%
154/229 • Number of events 228 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
56.8%
130/229 • Number of events 181 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
41.5%
95/229 • Number of events 259 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
38.0%
87/229 • Number of events 187 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.9%
25/229 • Number of events 50 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.1%
14/229 • Number of events 28 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
56.8%
130/229 • Number of events 320 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
55.0%
126/229 • Number of events 260 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
34.9%
80/229 • Number of events 157 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
31.9%
73/229 • Number of events 128 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
23/229 • Number of events 24 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
23/229 • Number of events 27 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
16.6%
38/229 • Number of events 50 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.6%
22/229 • Number of events 26 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.2%
12/229 • Number of events 14 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.5%
8/229 • Number of events 10 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
26.2%
60/229 • Number of events 76 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
29.7%
68/229 • Number of events 81 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.7%
45/229 • Number of events 56 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.1%
46/229 • Number of events 59 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
37.1%
85/229 • Number of events 141 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
35.8%
82/229 • Number of events 134 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
39/229 • Number of events 55 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.3%
19/229 • Number of events 27 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
20.5%
47/229 • Number of events 59 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.5%
40/229 • Number of events 61 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chest pain
|
3.1%
7/229 • Number of events 8 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.7%
13/229 • Number of events 14 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
25.3%
58/229 • Number of events 72 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
22.3%
51/229 • Number of events 55 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Malaise
|
5.7%
13/229 • Number of events 18 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.9%
9/229 • Number of events 14 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
6.1%
14/229 • Number of events 14 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.8%
11/229 • Number of events 11 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
10.5%
24/229 • Number of events 25 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
23/229 • Number of events 24 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
COVID-19
|
14.0%
32/229 • Number of events 34 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.3%
35/229 • Number of events 37 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
3.5%
8/229 • Number of events 8 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.2%
12/229 • Number of events 12 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
19/229 • Number of events 25 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.7%
13/229 • Number of events 17 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
16.2%
37/229 • Number of events 53 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
18.8%
43/229 • Number of events 62 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
14.8%
34/229 • Number of events 43 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
16.6%
38/229 • Number of events 53 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
23/229 • Number of events 38 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.2%
28/229 • Number of events 32 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood bilirubin increased
|
2.6%
6/229 • Number of events 18 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.2%
12/229 • Number of events 18 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
9.6%
22/229 • Number of events 32 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.4%
17/229 • Number of events 28 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.7%
20/229 • Number of events 35 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.1%
14/229 • Number of events 21 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.7%
20/229 • Number of events 25 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.1%
14/229 • Number of events 17 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
9.2%
21/229 • Number of events 24 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.7%
13/229 • Number of events 17 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.8%
75/229 • Number of events 93 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
19.2%
44/229 • Number of events 52 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.6%
22/229 • Number of events 34 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.4%
10/229 • Number of events 15 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.2%
12/229 • Number of events 19 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.1%
7/229 • Number of events 12 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.2%
28/229 • Number of events 53 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.2%
12/229 • Number of events 17 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.4%
17/229 • Number of events 22 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.7%
13/229 • Number of events 21 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.6%
22/229 • Number of events 30 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.6%
15/229 • Number of events 25 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.6%
38/229 • Number of events 51 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.9%
18/229 • Number of events 28 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
17.9%
41/229 • Number of events 65 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.3%
35/229 • Number of events 59 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
23/229 • Number of events 26 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.7%
20/229 • Number of events 26 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
21/229 • Number of events 22 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.2%
21/229 • Number of events 23 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
13/229 • Number of events 15 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.2%
12/229 • Number of events 21 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
9.2%
21/229 • Number of events 24 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.4%
17/229 • Number of events 21 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
5.2%
12/229 • Number of events 15 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.7%
13/229 • Number of events 13 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Headache
|
10.0%
23/229 • Number of events 27 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.9%
18/229 • Number of events 19 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
10.5%
24/229 • Number of events 29 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
9.6%
22/229 • Number of events 26 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
28/229 • Number of events 29 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.7%
20/229 • Number of events 22 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
24/229 • Number of events 27 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.4%
26/229 • Number of events 30 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.7%
13/229 • Number of events 14 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.8%
11/229 • Number of events 14 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.4%
88/229 • Number of events 90 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
37.1%
85/229 • Number of events 86 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.1%
14/229 • Number of events 16 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
3.9%
9/229 • Number of events 9 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.0%
48/229 • Number of events 62 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.8%
27/229 • Number of events 32 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.7%
52/229 • Number of events 70 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.4%
26/229 • Number of events 26 • Up to approximately 25 months
All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events (AEs) were reported on all randomized participants who received ≥1 dose of treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER