Trial Outcomes & Findings for Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61) (NCT NCT04704219)
NCT ID: NCT04704219
Last Updated: 2025-12-03
Results Overview
ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced a CR or PR as assessed per RECIST 1.1 by blinded independent central review (BICR) is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Up to approximately 47 months
Results posted on
2025-12-03
Participant Flow
This study was conducted at 56 centers in 14 countries.
Per protocol, six participants who experienced progression of Renal Cell Carcinoma (RCC) by radiographic evaluation continued second course treatment.
Participant milestones
| Measure |
Pembrolizumab + Lenvatinib
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|
|
Overall Study
STARTED
|
160
|
|
Overall Study
Treated
|
158
|
|
Overall Study
Second Course Treatment
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
160
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Lenvatinib
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|
|
Overall Study
Screen Failure
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
78
|
|
Overall Study
Participants Ongoing
|
80
|
Baseline Characteristics
Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Lenvatinib
n=160 Participants
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
60 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
137 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 47 monthsPopulation: All allocated participants who received at least one dose of study treatment.
ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced a CR or PR as assessed per RECIST 1.1 by blinded independent central review (BICR) is presented.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib
n=158 Participants
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|
|
Objective Response Rate (ORR)
|
50.6 Percentage of participants
Interval 42.6 to 58.7
|
SECONDARY outcome
Timeframe: Up to approximately 47 monthsPopulation: All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response.
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. Duration of response per RECIST 1.1 by Blinded Independent Central Review (BICR) is presented.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib
n=80 Participants
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|
|
Duration of Response (DOR)
|
23.5 Months
Interval 16.5 to 29.5
|
SECONDARY outcome
Timeframe: Up to approximately 47 monthsPopulation: All allocated participants who received at least 1 dose of study intervention.
PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by Blinded Independent Central Review (BICR) is presented.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib
n=158 Participants
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|
|
Progression Free Survival (PFS)
|
17.9 Months
Interval 15.0 to 21.1
|
SECONDARY outcome
Timeframe: Up to approximately 47 monthsPopulation: All allocated participants who received at least 1 dose of study intervention.
OS was defined as the time from the date of study treatment to the date of death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants is presented.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib
n=158 Participants
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|
|
Overall Survival (OS)
|
41.5 Months
Interval 32.8 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to approximately 47 monthsPopulation: All allocated participants who received at least 1 dose of study intervention.
CBR is defined as the percentage of participants who have achieved Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]) of ≥6 months per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR).
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib
n=158 Participants
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
71.5 Percentage of participants
Interval 63.8 to 78.4
|
SECONDARY outcome
Timeframe: Up to approximately 47 monthsPopulation: All allocated participants who received at least 1 dose of study intervention.
DCR was defined per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]). The appearance of one or more new lesions is also considered PD\]). Disease Control rate per RECIST 1.1 by Blinded Independent Central Review (BICR) is presented.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib
n=158 Participants
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|
|
Disease Control Rate (DCR)
|
82.3 Percentage of Participants
Interval 75.4 to 87.9
|
SECONDARY outcome
Timeframe: Up to approximately 56 monthsAn AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one or more AE is presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 56 monthsAn AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one or more AE is presented.
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab + Lenvatinib
Serious events: 76 serious events
Other events: 155 other events
Deaths: 79 deaths
Pembrolizumab + Lenvatinib Second Course
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pembrolizumab + Lenvatinib
n=158 participants at risk
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
Pembrolizumab + Lenvatinib Second Course
n=6 participants at risk
Participants who experienced progression of Renal Cell Carcinoma (RCC) by radiographic evaluation continued second course treatment of 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 1 year PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
4/158 • Number of events 4 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
4/158 • Number of events 4 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Bradycardia
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Cardiac arrest
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Cardiac failure
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Hypothyroidism
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Heart failure with reduced ejection fraction
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Cardiac disorders
Myocardial infarction
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Immune-mediated hypothyroidism
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Eye disorders
Retinal detachment
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Anal fistula
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/158 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
4/158 • Number of events 4 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.63%
1/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Melaena
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Proctitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Asthenia
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Death
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/158 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Pyrexia
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Abdominal abscess
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Acute sinusitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Appendicitis
|
2.5%
4/158 • Number of events 4 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
COVID-19
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Cellulitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Diverticulitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Infection
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Peritonitis
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Pharyngitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Pneumonia
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Sepsis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
4/158 • Number of events 4 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Blood creatinine increased
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Haemoglobin increased
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
3/158 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.9%
3/158 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Headache
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Myelitis transverse
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Presyncope
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Seizure
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Tremor
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Completed suicide
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Hallucination
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Major depression
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Suicidal ideation
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.8%
6/158 • Number of events 6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
3/158 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Embolism
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Haematoma
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Hypertension
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Hypotension
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Vasculitis
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
Other adverse events
| Measure |
Pembrolizumab + Lenvatinib
n=158 participants at risk
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
Pembrolizumab + Lenvatinib Second Course
n=6 participants at risk
Participants who experienced progression of Renal Cell Carcinoma (RCC) by radiographic evaluation continued second course treatment of 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 1 year PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.4%
18/158 • Number of events 25 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
15.2%
24/158 • Number of events 27 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Endocrine disorders
Hypothyroidism
|
44.3%
70/158 • Number of events 102 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
25/158 • Number of events 33 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.1%
16/158 • Number of events 21 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Constipation
|
19.6%
31/158 • Number of events 39 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
55.7%
88/158 • Number of events 238 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
21/158 • Number of events 21 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
9/158 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.5%
15/158 • Number of events 17 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.3%
10/158 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Nausea
|
32.3%
51/158 • Number of events 79 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Odynophagia
|
5.7%
9/158 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
20.9%
33/158 • Number of events 49 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Toothache
|
5.1%
8/158 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
27/158 • Number of events 42 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Asthenia
|
25.9%
41/158 • Number of events 52 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Chest pain
|
7.0%
11/158 • Number of events 12 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Fatigue
|
37.3%
59/158 • Number of events 75 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Mucosal inflammation
|
15.8%
25/158 • Number of events 39 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Oedema peripheral
|
12.0%
19/158 • Number of events 22 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
General disorders
Pyrexia
|
8.9%
14/158 • Number of events 14 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
COVID-19
|
24.7%
39/158 • Number of events 44 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Gastroenteritis
|
1.9%
3/158 • Number of events 4 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
8/158 • Number of events 8 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Pertussis
|
0.00%
0/158 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
14/158 • Number of events 26 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Infections and infestations
Urinary tract infection
|
9.5%
15/158 • Number of events 27 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
17.7%
28/158 • Number of events 39 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Amylase increased
|
8.9%
14/158 • Number of events 35 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
18.4%
29/158 • Number of events 41 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.6%
12/158 • Number of events 18 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Blood bilirubin increased
|
5.1%
8/158 • Number of events 12 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Blood creatinine increased
|
12.7%
20/158 • Number of events 31 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
11.4%
18/158 • Number of events 19 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Lipase increased
|
10.8%
17/158 • Number of events 25 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Investigations
Weight decreased
|
29.1%
46/158 • Number of events 58 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.2%
54/158 • Number of events 72 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.2%
5/158 • Number of events 8 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.5%
15/158 • Number of events 16 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.3%
10/158 • Number of events 14 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.6%
50/158 • Number of events 90 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.4%
7/158 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.1%
27/158 • Number of events 31 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.7%
9/158 • Number of events 10 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.6%
23/158 • Number of events 29 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.1%
16/158 • Number of events 17 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Dizziness
|
10.8%
17/158 • Number of events 17 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Dysgeusia
|
10.8%
17/158 • Number of events 20 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Nervous system disorders
Headache
|
22.8%
36/158 • Number of events 45 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Psychiatric disorders
Insomnia
|
9.5%
15/158 • Number of events 17 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.63%
1/158 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Renal and urinary disorders
Haematuria
|
6.3%
10/158 • Number of events 11 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Renal and urinary disorders
Proteinuria
|
37.3%
59/158 • Number of events 93 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.6%
31/158 • Number of events 37 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
32.3%
51/158 • Number of events 67 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.6%
23/158 • Number of events 25 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.1%
16/158 • Number of events 19 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.2%
13/158 • Number of events 13 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.3%
2/158 • Number of events 2 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.7%
9/158 • Number of events 9 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
11/158 • Number of events 14 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
31.6%
50/158 • Number of events 84 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.6%
31/158 • Number of events 40 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.6%
23/158 • Number of events 24 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.5%
15/158 • Number of events 20 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Hypertension
|
60.1%
95/158 • Number of events 174 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
|
Vascular disorders
Hypotension
|
5.1%
8/158 • Number of events 9 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
|
0.00%
0/6 • Up to approximately 56 months
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were 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 was not directed by the Sponsor, the investigator agreed to submit all manuscripts or abstracts to the Sponsor before submission. This allowed the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER