Trial Outcomes & Findings for Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008) (NCT NCT03976375)
NCT ID: NCT03976375
Last Updated: 2025-08-15
Results Overview
OS is defined as the time from randomization to the date of death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
422 participants
Primary outcome timeframe
Up to ~47 months
Results posted on
2025-08-15
Participant Flow
Participant milestones
| Measure |
Pembrolizumab+Lenvatinib
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
185
|
189
|
48
|
|
Overall Study
Treated
|
181
|
177
|
47
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
185
|
189
|
48
|
Reasons for withdrawal
| Measure |
Pembrolizumab+Lenvatinib
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Death
|
158
|
160
|
42
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
9
|
4
|
|
Overall Study
Sponsor decision
|
20
|
19
|
1
|
Baseline Characteristics
Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)
Baseline characteristics by cohort
| Measure |
Pembrolizumab+Lenvatinib
n=185 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=189 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib
n=48 Participants
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Total
n=422 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.2 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
64.3 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
64.0 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
160 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
360 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
146 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
316 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) at baseline
ECOG 0
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) at baseline
ECOG 1
|
118 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
271 Participants
n=4 Participants
|
|
Sequence of Prior Anti-programmed cell death protein 1 (PD-1)/PD-L1 Therapy
Immediate Prior Therapy -Anti-PD-1/PD-L1
|
145 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
333 Participants
n=4 Participants
|
|
Sequence of Prior Anti-programmed cell death protein 1 (PD-1)/PD-L1 Therapy
Not Immediate Prior Therapy--Anti-PD-1/PD-L1
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Programmed cell death ligand 1 (PD-L1)Status
TPS<50%
|
135 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
309 Participants
n=4 Participants
|
|
Programmed cell death ligand 1 (PD-L1)Status
TPS>=50%
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Programmed cell death ligand 1 (PD-L1)Status
Unknown
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to ~47 monthsPopulation: All randomized participants, included in the treatment group to which they were randomized. Per protocol, participants in the lenvatinib monotherapy arm were not analyzed.
OS is defined as the time from randomization to the date of death due to any cause.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=185 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=189 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival (OS)
|
11.3 Months
Interval 9.4 to 13.2
|
12.0 Months
Interval 9.6 to 13.7
|
—
|
PRIMARY outcome
Timeframe: Up to ~47 monthsPopulation: All randomized participants, included in the treatment group to which they were randomized. Per protocol, participants in the lenvatinib monotherapy arm were not analyzed.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS was assessed by blinded independent central review (BICR) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=185 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=189 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
5.6 Months
Interval 4.2 to 6.5
|
4.2 Months
Interval 3.2 to 5.2
|
—
|
SECONDARY outcome
Timeframe: Up to ~47 monthsPopulation: All randomized participants, included in the treatment group to which they were randomized. Per protocol, participants in the lenvatinib monotherapy arm were not analyzed.
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). ORR was assessed by BICR per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=185 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=189 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel
|
22.7 Percentage of Participants
Interval 16.9 to 29.4
|
14.3 Percentage of Participants
Interval 9.6 to 20.1
|
—
|
SECONDARY outcome
Timeframe: Up to ~47 monthsPopulation: All randomized participants, included in the treatment group to which they were randomized. Per protocol, participants in the docetaxel arm were not analyzed.
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). ORR was assessed by BICR per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=185 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=48 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy
|
22.7 Percentage of Participants
Interval 16.9 to 29.4
|
12.5 Percentage of Participants
Interval 4.7 to 25.2
|
—
|
SECONDARY outcome
Timeframe: Up to ~47 monthsPopulation: All randomized participants who had a confirmed or partial response, included in the treatment group to which they were randomized. Per protocol, participants in the lenvatinib monotherapy arm were not analyzed.
DOR is defined as the time from first documented evidence of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) until disease progression or death due to any cause, whichever occurs first. DOR was assessed by BICR per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=42 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=27 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
6.9 Months
Interval 2.3 to
NA= Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
|
6.8 Months
NA= lower limit, upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
|
—
|
SECONDARY outcome
Timeframe: Up to ~47 monthsPopulation: All randomized participants who received at least 1 dose of study intervention
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE is presented.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=181 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=177 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
n=47 Participants
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
179 Participants
|
174 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Up to ~47 monthsPopulation: All randomized participants who received at least 1 dose of study intervention
The number of participants who discontinued study treatment due to an AE is presented.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=181 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=177 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
n=47 Participants
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Number of Participants Discontinuing Study Treatment Due to an AE
|
68 Participants
|
43 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of cancer patients, including a combined global health status (GHS)/QoL (Items 29 and 30) scale. For each item, scores range from 0-100, with higher scores indicating higher GHS/QoL. Per protocol, scores for items 29 and 30 will be averaged to compute a combined GHS/QoL scale score. Change from baseline in the combined GHS/QoL scale scores is presented.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=181 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=176 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
|
-2.48 Scores on a scale
Interval -5.44 to 0.49
|
-1.12 Scores on a scale
Interval -4.22 to 1.98
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-LC13 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for cough (Item 31). For this item, individual responses to the question "How much did you cough?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 cough (Item 31) scale score is presented.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=181 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=175 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score
|
-4.17 Scores on a scale
Interval -8.08 to -0.27
|
-0.32 Scores on a scale
Interval -4.4 to 3.77
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-LC13 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for chest pain (Item 40). For this item, individual responses to the question "Have you had pain in your chest?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 chest pain (Item 40) scale score is presented.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=181 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=175 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
|
-1.40 Scores on a scale
Interval -4.92 to 2.12
|
-3.88 Scores on a scale
Interval -7.58 to -0.18
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a single-item scale score for dyspnea (Item 8). For this item, individual responses to the question "Were you short of breath?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 dyspnea (Item 8) scale score is presented.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=181 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=176 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
|
-2.92 Scores on a scale
Interval -7.08 to 1.23
|
5.12 Scores on a scale
Interval 0.79 to 9.45
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a physical functioning (PF) scale (Items 1 to 5). The PF scale consists of participant responses to 5 questions regarding performance of daily activities \[1) strenuous activities; 2) long walks; 3) short walks; 4) bed/chair rest; and 5) needing help with eating, dressing, washing themselves or using the toilet\]. Overall PF scores range from 0 to 100, with a lower score indicating a better outcome. The change from Baseline in the EORTC QLQ-C30 PF (Items 1 to 5) scale combined score is presented.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=181 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=176 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score
|
-5.58 Scores on a scale
Interval -8.51 to -2.65
|
-8.47 Scores on a scale
Interval -11.51 to -5.43
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a combined GHS/QoL (Items 29 and 30) scale. The TTD in the combined GHS/QoL (Items 29 \& 30) scale combined score is presented, defined as the time to first onset of a ≥10 point decrease from baseline. A longer TTD indicates a better outcome
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=175 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=167 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
|
8.51 Months
Interval 6.24 to
NA= Upper limit not reached
|
9.59 Months
Interval 5.78 to
NA=Upper limit not reached
|
—
|
SECONDARY outcome
Timeframe: Up to ~24 monthsPopulation: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-LC13 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for cough (Item 31). The TTD in EORTC QLQ-LC13 cough (Item 31) scale score is presented, defined as the time to first onset of a ≥10 point decrease from baseline.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=173 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=164 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score
|
NA Months
NA=median, lower limit and upper limit not reached
|
NA Months
Interval 10.97 to
NA=median, upper limit not reached
|
—
|
SECONDARY outcome
Timeframe: Up to ~24 monthsPopulation: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms. who have at least 1 EORTC QLQ-LC13 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
Used in combination with QLQ-C30, the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, including a single-item scale score for chest pain (Item 40). The TTD in EORTC QLQ-LC13 chest pain (Item 40) scale score is presented, defined as the time to first onset of a ≥10 point decrease from baseline.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=173 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=164 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
|
NA Months
NA= median, lower limit, upper limit not reached
|
NA Months
NA= median, lower limit, upper limit not reached
|
—
|
SECONDARY outcome
Timeframe: Up to ~24 monthsPopulation: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a single-item scale score for dyspnea (Item 8). The TTD in dyspnea (Item 8) scale score will be presented, defined as the time to first onset of a ≥10 point decrease from baseline.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=175 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=167 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
|
NA Months
NA=median, lower limit, upper limit not reached
|
NA Months
Interval 10.84 to
NA=Median, upper limit not reached
|
—
|
SECONDARY outcome
Timeframe: Up to ~24 monthsPopulation: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients, including a physical functioning (PF) scale (Items 1 to 5). The TTD in PF (Items 1 to 5) scale combined score is presented, defined as the time to first onset of a ≥10 point decrease from baseline.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=175 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=167 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score
|
6.70 Months
Interval 5.36 to 9.86
|
7.03 Months
Interval 4.76 to
NA=upper limit not reached
|
—
|
SECONDARY outcome
Timeframe: Up to ~ 24 monthsPopulation: Randomized participants in pembrolizumab + lenvatinib and docetaxel arms, who have at least 1 EORTC QLQ-C30 and EORTC QLC-LC13 assessment available and have received at least 1 dose of study intervention. Participants were analyzed in the treatment group to which they were randomized.
EORTC QLQ-C30 includes a single-item scale score for dyspnea (Item 8), the EORTC QLQ-LC13 is a supplemental lung cancer-specific module, which includes a single-item scale score for cough (Item 31) and chest pain (Item 40). Time to True Deterioration for the Composite Endpoint of EORTC QLQ- LC13 Cough, EORTC QLQ- LC13 Chest Pain, or EORTC QLQ-C30 Dyspnea is presented, defined as the time to first onset of a ≥10-point decrease from baseline in any one of 3 scale items with confirmation by the subsequent visit of a 10 or more-point deterioration from baseline in the same scale as the first onset under right-censoring rule.
Outcome measures
| Measure |
Pembrolizumab+Lenvatinib
n=175 Participants
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=167 Participants
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib Monotherapy
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Time to True Deterioration (TTD) in EORTC Composite Symptom Score for Cough (QLQ-LC13 Item 31), Chest Pain (QLQ-LC13 Item 40), or Dyspnea (QLQ-C30 Item 8)
|
9.20 Months
Interval 5.59 to 12.62
|
5.55 Months
Interval 3.48 to 12.78
|
—
|
Adverse Events
Pembrolizumab + Lenvatinib
Serious events: 99 serious events
Other events: 170 other events
Deaths: 161 deaths
Docetaxel
Serious events: 66 serious events
Other events: 165 other events
Deaths: 164 deaths
Lenvatinib
Serious events: 28 serious events
Other events: 45 other events
Deaths: 46 deaths
Serious adverse events
| Measure |
Pembrolizumab + Lenvatinib
n=181 participants at risk
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=177 participants at risk
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib
n=47 participants at risk
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Infections and infestations
Orchitis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.5%
8/177 • Number of events 8 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Angina pectoris
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Angina unstable
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Atrial fibrillation
|
0.55%
1/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Cardiac failure
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.7%
3/181 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Endocrine disorders
Hypoaldosteronism
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Endocrine disorders
Hypophysitis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Anal fissure
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Colitis
|
2.2%
4/181 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Constipation
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
7/181 • Number of events 7 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.55%
1/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Duodenitis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Asthenia
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Condition aggravated
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Death
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Gait disturbance
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
General physical health deterioration
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Inadequate analgesia
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Malaise
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Pain
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Pyrexia
|
1.7%
3/181 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Sudden death
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Hepatobiliary disorders
Jaundice
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Anal abscess
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
COVID-19
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Cholecystitis infective
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Empyema
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Gastroenteritis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Gastrointestinal infection
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.3%
4/177 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Oral candidiasis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Paronychia
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Pneumonia
|
5.5%
10/181 • Number of events 12 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
5.1%
9/177 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.3%
2/47 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Postoperative wound infection
|
0.55%
1/181 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Scrotal abscess
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Sepsis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Subcutaneous abscess
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Wound infection
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Delayed effects of radiation
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Blood bilirubin increased
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Hepatic enzyme increased
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Neutrophil count decreased
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
4/181 • Number of events 7 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Autoimmune encephalopathy
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Encephalitis toxic
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Encephalopathy
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Seizure
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Toxic leukoencephalopathy
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Psychiatric disorders
Delirium
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Renal and urinary disorders
Renal failure
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
4/181 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.7%
3/181 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
6/181 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.3%
2/47 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Vascular disorders
Hypertension
|
2.2%
4/181 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.3%
2/47 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
Other adverse events
| Measure |
Pembrolizumab + Lenvatinib
n=181 participants at risk
Participants received pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab is administered for up to 35 treatment cycles (\~2 years). Lenvantinib is administered until progressive disease or unacceptable toxicity.
|
Docetaxel
n=177 participants at risk
Participants received docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel is administered until progressive disease or unacceptable toxicity.
|
Lenvatinib
n=47 participants at risk
Participants received lenvatinib at 24 mg, QD via oral capsule. Lenvatinib is administered until progressive disease or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.7%
23/181 • Number of events 25 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
28.2%
50/177 • Number of events 56 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.3%
2/47 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.55%
1/181 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
5.1%
9/177 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
4.4%
8/181 • Number of events 9 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Endocrine disorders
Hypothyroidism
|
35.4%
64/181 • Number of events 74 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.7%
3/177 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
36.2%
17/47 • Number of events 17 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.4%
26/181 • Number of events 34 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.8%
5/177 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
19.1%
9/47 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
15/181 • Number of events 18 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.7%
3/177 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
8.5%
4/47 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Constipation
|
14.9%
27/181 • Number of events 33 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
9.0%
16/177 • Number of events 19 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
25.5%
12/47 • Number of events 13 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.9%
74/181 • Number of events 133 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
19.8%
35/177 • Number of events 44 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
38.3%
18/47 • Number of events 38 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
5/181 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
14.9%
7/47 • Number of events 7 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
15/181 • Number of events 16 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Nausea
|
22.1%
40/181 • Number of events 56 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
18.6%
33/177 • Number of events 37 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
34.0%
16/47 • Number of events 21 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
17.7%
32/181 • Number of events 39 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
10.7%
19/177 • Number of events 21 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
21.3%
10/47 • Number of events 13 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
31/181 • Number of events 45 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
10.7%
19/177 • Number of events 23 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
25.5%
12/47 • Number of events 20 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Asthenia
|
27.6%
50/181 • Number of events 61 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
26.6%
47/177 • Number of events 54 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
25.5%
12/47 • Number of events 14 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Chest pain
|
6.6%
12/181 • Number of events 12 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
3.4%
6/177 • Number of events 7 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
12.8%
6/47 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Fatigue
|
23.2%
42/181 • Number of events 54 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
21.5%
38/177 • Number of events 47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
34.0%
16/47 • Number of events 18 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Oedema peripheral
|
9.4%
17/181 • Number of events 19 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
14.7%
26/177 • Number of events 26 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
General disorders
Pyrexia
|
5.5%
10/181 • Number of events 11 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
18.6%
33/177 • Number of events 46 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.3%
2/47 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
15/181 • Number of events 17 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
3.4%
6/177 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
14.9%
7/47 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
3/181 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.56%
1/177 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
8.5%
4/47 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Alanine aminotransferase increased
|
10.5%
19/181 • Number of events 26 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.0%
7/177 • Number of events 11 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.3%
2/47 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Amylase increased
|
9.4%
17/181 • Number of events 20 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.7%
3/177 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
10.5%
19/181 • Number of events 33 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
3.4%
6/177 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.3%
2/47 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
15/181 • Number of events 18 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.3%
4/177 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.3%
2/47 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Blood creatinine increased
|
9.4%
17/181 • Number of events 21 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.7%
3/177 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
12.7%
23/181 • Number of events 28 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Lipase increased
|
7.7%
14/181 • Number of events 17 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.8%
5/177 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Neutrophil count decreased
|
5.0%
9/181 • Number of events 11 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
20.3%
36/177 • Number of events 63 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Platelet count decreased
|
14.4%
26/181 • Number of events 30 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.3%
4/177 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
12.8%
6/47 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
Weight decreased
|
19.3%
35/181 • Number of events 37 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
5.1%
9/177 • Number of events 9 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
21.3%
10/47 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Investigations
White blood cell count decreased
|
1.1%
2/181 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
7.9%
14/177 • Number of events 20 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.5%
57/181 • Number of events 68 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
20.3%
36/177 • Number of events 38 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
27.7%
13/47 • Number of events 16 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.5%
10/181 • Number of events 11 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.5%
8/177 • Number of events 9 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.4%
17/181 • Number of events 25 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
5.1%
9/177 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
14/181 • Number of events 17 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.0%
7/177 • Number of events 8 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.1%
11/181 • Number of events 16 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.0%
7/177 • Number of events 13 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.6%
30/181 • Number of events 36 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.2%
11/177 • Number of events 13 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
8.5%
4/47 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
16/181 • Number of events 17 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
5.6%
10/177 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
3/181 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
8.5%
4/47 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
16/181 • Number of events 16 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
11.3%
20/177 • Number of events 23 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.5%
10/181 • Number of events 14 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
5.6%
10/177 • Number of events 11 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
8.5%
4/47 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Dizziness
|
10.5%
19/181 • Number of events 22 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.2%
11/177 • Number of events 12 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
10.6%
5/47 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Dysgeusia
|
6.1%
11/181 • Number of events 11 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.0%
7/177 • Number of events 9 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Headache
|
11.0%
20/181 • Number of events 27 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.8%
5/177 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
12.8%
6/47 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Lethargy
|
1.7%
3/181 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.2%
4/181 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
8.5%
15/177 • Number of events 19 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Paraesthesia
|
1.1%
2/181 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
7.9%
14/177 • Number of events 14 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.8%
12/177 • Number of events 15 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.1%
1/47 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Renal and urinary disorders
Proteinuria
|
19.9%
36/181 • Number of events 50 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
14.9%
7/47 • Number of events 14 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.9%
27/181 • Number of events 28 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
7.9%
14/177 • Number of events 16 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
10.6%
5/47 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
11.6%
21/181 • Number of events 26 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.8%
5/177 • Number of events 7 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
19.1%
9/47 • Number of events 11 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
24/181 • Number of events 25 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
13.6%
24/177 • Number of events 24 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
14.9%
7/47 • Number of events 8 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
14/181 • Number of events 16 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
1.1%
2/177 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.7%
14/181 • Number of events 24 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.5%
8/177 • Number of events 9 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
10/181 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.3%
4/177 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/177 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
6.4%
3/47 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.7%
3/181 • Number of events 3 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
26.0%
46/177 • Number of events 46 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.4%
8/181 • Number of events 8 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.8%
5/177 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
12.8%
6/47 • Number of events 6 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.55%
1/181 • Number of events 1 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
5.6%
10/177 • Number of events 10 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/181 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
5.1%
9/177 • Number of events 9 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
0.00%
0/47 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
6.6%
12/181 • Number of events 14 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
2.3%
4/177 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
8.5%
4/47 • Number of events 5 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.7%
23/181 • Number of events 30 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
5.1%
9/177 • Number of events 9 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.3%
2/47 • Number of events 2 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.0%
20/181 • Number of events 31 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
4.0%
7/177 • Number of events 7 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
8.5%
4/47 • Number of events 4 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
|
Vascular disorders
Hypertension
|
41.4%
75/181 • Number of events 128 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
3.4%
6/177 • Number of events 7 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
51.1%
24/47 • Number of events 34 • Up to approximately 59 months
The population for all-cause mortality includes all participants in the treatment arm to which they were randomized. SAE and other AEs population includes all randomized participants who received at least 1 dose of study intervention. MedDRA preferred terms 'Neoplasm progression' 'Malignant neoplasm progression' and 'Disease progression' not related to the drug are excluded.
|
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.
- Publication restrictions are in place
Restriction type: OTHER