Trial Outcomes & Findings for Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02) (NCT NCT04305041)
NCT ID: NCT04305041
Last Updated: 2026-08-13
Results Overview
An AE was 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. The percentage of participants who experienced an AE is reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Up to approximately 39 months
Results posted on
2026-08-13
Participant Flow
100 participants were randomized to one of three investigational arms: Pembrolizumab + Quavonlimab + Vibostolimab, Pembrolizumab + Quavonlimab + Lenvatinib, or Pembrolizumab + all-trans retinoic acid (ATRA).
Participant milestones
| Measure |
Pembrolizumab + Quavonlimab + Vibostolimab
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) PLUS quavonlimab 25 mg IV on Day 1 of each 6-week cycle (Q6W) PLUS vibostolimab 200 mg IV on Day 1 Q3W for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Lenvatinib
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS quavonlimab 25 mg IV on Day 1 Q6W PLUS lenvatinib 20 mg orally once daily for up to approximately 2 years.
|
Pembrolizumab + All-trans Retinoic Acid (ATRA)
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS ATRA 75 mg/m\^2 orally twice per day on Days 1 through 3 Q3W for up to approximately 2 years.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
20
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
40
|
40
|
20
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Quavonlimab + Vibostolimab
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) PLUS quavonlimab 25 mg IV on Day 1 of each 6-week cycle (Q6W) PLUS vibostolimab 200 mg IV on Day 1 Q3W for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Lenvatinib
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS quavonlimab 25 mg IV on Day 1 Q6W PLUS lenvatinib 20 mg orally once daily for up to approximately 2 years.
|
Pembrolizumab + All-trans Retinoic Acid (ATRA)
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS ATRA 75 mg/m\^2 orally twice per day on Days 1 through 3 Q3W for up to approximately 2 years.
|
|---|---|---|---|
|
Overall Study
Death
|
32
|
33
|
16
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
6
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
Baseline Characteristics
Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Quavonlimab + Vibostolimab
n=40 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) PLUS quavonlimab 25 mg IV on Day 1 of each 6-week cycle (Q6W) PLUS vibostolimab 200 mg IV on Day 1 Q3W for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Lenvatinib
n=40 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS quavonlimab 25 mg IV on Day 1 Q6W PLUS lenvatinib 20 mg orally once daily for up to approximately 2 years.
|
Pembrolizumab + All-trans Retinoic Acid (ATRA)
n=20 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS ATRA 75 mg/m\^2 orally twice per day on Days 1 through 3 Q3W for up to approximately 2 years.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 12.9 • n=1 Participants
|
60.5 Years
STANDARD_DEVIATION 13.4 • n=1 Participants
|
61.8 Years
STANDARD_DEVIATION 16.7 • n=1 Participants
|
61.1 Years
STANDARD_DEVIATION 13.8 • n=2 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
30 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=1 Participants
|
34 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
70 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=1 Participants
|
26 Participants
n=1 Participants
|
18 Participants
n=1 Participants
|
72 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=1 Participants
|
13 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
26 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=1 Participants
|
31 Participants
n=1 Participants
|
17 Participants
n=1 Participants
|
84 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=1 Participants
|
9 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
16 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 39 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment.
An AE was 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. The percentage of participants who experienced an AE is reported.
Outcome measures
| Measure |
Pembrolizumab + All-trans Retinoic Acid (ATRA)
n=20 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS ATRA 75 mg/m\^2 orally twice per day on Days 1 through 3 Q3W for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Lenvatinib
n=40 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS quavonlimab 25 mg IV on Day 1 Q6W PLUS lenvatinib 20 mg orally once daily for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Vibostolimab
n=40 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) PLUS quavonlimab 25 mg IV on Day 1 of each 6-week cycle (Q6W) PLUS vibostolimab 200 mg IV on Day 1 Q3W for up to approximately 2 years.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced an Adverse Event (AE)
|
95.0 Percentage of Participants
|
100.0 Percentage of Participants
|
97.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 35 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment.
An AE was 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. The percentage of participants who discontinued study treatment due to an AE is reported.
Outcome measures
| Measure |
Pembrolizumab + All-trans Retinoic Acid (ATRA)
n=20 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS ATRA 75 mg/m\^2 orally twice per day on Days 1 through 3 Q3W for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Lenvatinib
n=40 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS quavonlimab 25 mg IV on Day 1 Q6W PLUS lenvatinib 20 mg orally once daily for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Vibostolimab
n=40 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) PLUS quavonlimab 25 mg IV on Day 1 of each 6-week cycle (Q6W) PLUS vibostolimab 200 mg IV on Day 1 Q3W for up to approximately 2 years.
|
|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Treatment Due to an AE
|
0.0 Percentage of Participants
|
30.0 Percentage of Participants
|
15.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to approximately 59 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment.
ORR was defined as the percentage of participants in the analysis population 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, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 was modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Per protocol, ORR with 95% CI was reported.
Outcome measures
| Measure |
Pembrolizumab + All-trans Retinoic Acid (ATRA)
n=20 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS ATRA 75 mg/m\^2 orally twice per day on Days 1 through 3 Q3W for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Lenvatinib
n=40 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS quavonlimab 25 mg IV on Day 1 Q6W PLUS lenvatinib 20 mg orally once daily for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Vibostolimab
n=40 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) PLUS quavonlimab 25 mg IV on Day 1 of each 6-week cycle (Q6W) PLUS vibostolimab 200 mg IV on Day 1 Q3W for up to approximately 2 years.
|
|---|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) With 95% Confidence Interval (CI)
|
0.0 Percentage of Participants
Interval 0.0 to 16.8
|
27.5 Percentage of Participants
Interval 14.6 to 43.9
|
17.5 Percentage of Participants
Interval 7.3 to 32.8
|
PRIMARY outcome
Timeframe: Up to approximately 59 monthsPopulation: The analysis population consisted of all participants who received at least 1 dose of study treatment.
ORR was defined as the percentage of participants in the analysis population 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, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Per protocol, ORR with 90% CI was reported.
Outcome measures
| Measure |
Pembrolizumab + All-trans Retinoic Acid (ATRA)
n=20 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS ATRA 75 mg/m\^2 orally twice per day on Days 1 through 3 Q3W for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Lenvatinib
n=40 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS quavonlimab 25 mg IV on Day 1 Q6W PLUS lenvatinib 20 mg orally once daily for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Vibostolimab
n=40 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) PLUS quavonlimab 25 mg IV on Day 1 of each 6-week cycle (Q6W) PLUS vibostolimab 200 mg IV on Day 1 Q3W for up to approximately 2 years.
|
|---|---|---|---|
|
ORR Per RECIST 1.1 With 90% CI
|
0.0 Percentage of Participants
Interval 0.0 to 13.9
|
27.5 Percentage of Participants
Interval 16.3 to 41.4
|
17.5 Percentage of Participants
Interval 8.5 to 30.4
|
SECONDARY outcome
Timeframe: Up to approximately 59 monthsPopulation: The analysis population consisted of all participants who received ≥1 dose of study treatment and had confirmed CR or PR. No participants in the pembrolizumab + ATRA arm experienced confirmed CR or PR.
For participants in the analysis population who showed a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Outcome measures
| Measure |
Pembrolizumab + All-trans Retinoic Acid (ATRA)
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS ATRA 75 mg/m\^2 orally twice per day on Days 1 through 3 Q3W for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Lenvatinib
n=11 Participants
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS quavonlimab 25 mg IV on Day 1 Q6W PLUS lenvatinib 20 mg orally once daily for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Vibostolimab
n=7 Participants
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) PLUS quavonlimab 25 mg IV on Day 1 of each 6-week cycle (Q6W) PLUS vibostolimab 200 mg IV on Day 1 Q3W for up to approximately 2 years.
|
|---|---|---|---|
|
Duration of Response (DOR) Per RECIST 1.1
|
—
|
14.8 Months
Interval 3.9 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
9.8 Months
Interval 4.1 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
|
Adverse Events
Pembrolizumab + Quavonlimab + Vibostolimab
Serious events: 11 serious events
Other events: 39 other events
Deaths: 32 deaths
Pembrolizumab + Quavonlimab + Lenvatinib
Serious events: 21 serious events
Other events: 40 other events
Deaths: 34 deaths
Pembrolizumab + All-trans Retinoic Acid (ATRA)
Serious events: 6 serious events
Other events: 18 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Pembrolizumab + Quavonlimab + Vibostolimab
n=40 participants at risk
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) PLUS quavonlimab 25 mg IV on Day 1 of each 6-week cycle (Q6W) PLUS vibostolimab 200 mg IV on Day 1 Q3W for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Lenvatinib
n=40 participants at risk
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS quavonlimab 25 mg IV on Day 1 Q6W PLUS lenvatinib 20 mg orally once daily for up to approximately 2 years.
|
Pembrolizumab + All-trans Retinoic Acid (ATRA)
n=20 participants at risk
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS ATRA 75 mg/m\^2 orally twice per day on Days 1 through 3 Q3W for up to approximately 2 years.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
2/40 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
2/40 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrial flutter
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
General physical health deterioration
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatitis
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Troponin increased
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.5%
1/40 • Number of events 6 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Carotid sinus syndrome
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Hemiparesis
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Product Issues
Device occlusion
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Autoimmune blistering disease
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab + Quavonlimab + Vibostolimab
n=40 participants at risk
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) PLUS quavonlimab 25 mg IV on Day 1 of each 6-week cycle (Q6W) PLUS vibostolimab 200 mg IV on Day 1 Q3W for up to approximately 2 years.
|
Pembrolizumab + Quavonlimab + Lenvatinib
n=40 participants at risk
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS quavonlimab 25 mg IV on Day 1 Q6W PLUS lenvatinib 20 mg orally once daily for up to approximately 2 years.
|
Pembrolizumab + All-trans Retinoic Acid (ATRA)
n=20 participants at risk
Participants received pembrolizumab 400 mg IV on Day 1 Q6W PLUS ATRA 75 mg/m\^2 orally twice per day on Days 1 through 3 Q3W for up to approximately 2 years.
|
|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
4/40 • Number of events 7 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
8/40 • Number of events 9 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
2/40 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
8/40 • Number of events 8 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
5/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
4/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
10/40 • Number of events 15 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.5%
7/40 • Number of events 7 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Lipase increased
|
7.5%
3/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
37.5%
15/40 • Number of events 17 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
5.0%
2/40 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
32.5%
13/40 • Number of events 15 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
White blood cell count increased
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
2/20 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
8/40 • Number of events 9 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
35.0%
14/40 • Number of events 17 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.0%
3/20 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
4/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
5/40 • Number of events 6 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
2/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
5/40 • Number of events 6 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.0%
3/20 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
2/40 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
5/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
2/20 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
5/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
6/40 • Number of events 7 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
37.5%
15/40 • Number of events 21 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
4/20 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
4/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
4/20 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.5%
7/40 • Number of events 8 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
2/20 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
35.0%
14/40 • Number of events 18 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
55.0%
11/20 • Number of events 14 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
2/20 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
2/20 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
5/40 • Number of events 6 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
45.0%
18/40 • Number of events 20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
4/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
2/40 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
4/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
2/20 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.0%
4/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.0%
6/40 • Number of events 7 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
12/40 • Number of events 14 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
5/40 • Number of events 6 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.0%
3/20 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
4/40 • Number of events 7 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
4/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
2/20 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.5%
7/40 • Number of events 9 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
5/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
4/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
55.0%
22/40 • Number of events 33 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
4/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
4/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
5/20 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
5/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.5%
7/40 • Number of events 8 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
2/20 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
2/40 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
35.0%
14/40 • Number of events 14 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Dry eye
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
10/40 • Number of events 12 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
2/20 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
3/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
4/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
6/40 • Number of events 6 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.0%
6/40 • Number of events 6 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
4/20 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.5%
11/40 • Number of events 20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
57.5%
23/40 • Number of events 41 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.0%
2/20 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
4/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
35.0%
14/40 • Number of events 14 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.0%
3/20 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
12.5%
5/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
17.5%
7/40 • Number of events 7 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.0%
6/40 • Number of events 7 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
4/20 • Number of events 6 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
2.5%
1/40 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
17.5%
7/40 • Number of events 7 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
2/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
5/20 • Number of events 8 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
32.5%
13/40 • Number of events 14 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
32.5%
13/40 • Number of events 15 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
4/20 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Chills
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
20.0%
8/40 • Number of events 10 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
10/40 • Number of events 13 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
5/20 • Number of events 6 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Influenza like illness
|
5.0%
2/40 • Number of events 2 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 4 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
17.5%
7/40 • Number of events 8 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.0%
5/20 • Number of events 6 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
COVID-19
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.5%
3/40 • Number of events 3 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.5%
3/40 • Number of events 9 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/40 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
4/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.0%
6/40 • Number of events 7 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
1/20 • Number of events 1 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Amylase increased
|
7.5%
3/40 • Number of events 5 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
20.0%
8/40 • Number of events 10 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/20 • Up to approximately 59 months
Serious and Other AEs include all randomized participants who received at least 1 dose of study treatment. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER