Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427) (NCT NCT02853344)
NCT ID: NCT02853344
Last Updated: 2023-04-11
Results Overview
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
275 participants
Primary outcome timeframe
Up to approximately 52 months
Results posted on
2023-04-11
Participant Flow
Participant milestones
| Measure |
Cohort A: Clear Cell Renal Cell Carcinoma (ccRCC)
Participants with ccRCC received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 doses (approximately 24 months). Eligible participants with ccRCC who experienced disease progression received a second course of up to 17 additional doses of pembrolizumab.
|
Cohort B: Non-clear Cell RCC (nccRCC)
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with nccRCC who experienced disease progression received a second course of up to 17 additional doses of pembrolizumab.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
165
|
|
Overall Study
Received Second Course of Pembrolizumab
|
3
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
110
|
165
|
Reasons for withdrawal
| Measure |
Cohort A: Clear Cell Renal Cell Carcinoma (ccRCC)
Participants with ccRCC received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 doses (approximately 24 months). Eligible participants with ccRCC who experienced disease progression received a second course of up to 17 additional doses of pembrolizumab.
|
Cohort B: Non-clear Cell RCC (nccRCC)
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with nccRCC who experienced disease progression received a second course of up to 17 additional doses of pembrolizumab.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Participation in Study Terminated by Sponsor
|
37
|
48
|
|
Overall Study
Death
|
70
|
112
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427)
Baseline characteristics by cohort
| Measure |
Cohort A: Clear Cell Renal Cell Carcinoma (ccRCC)
n=110 Participants
Participants with ccRCC received pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) for up to 35 doses (approximately 24 months).
|
Cohort B: Non-clear Cell RCC (nccRCC)
n=165 Participants
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Total
n=275 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
60.0 Years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
61.1 Years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 52 monthsPopulation: All allocated participants who received at least one dose of study treatment
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Outcome measures
| Measure |
Cohort A: Clear Cell RCC (ccRCC)
n=110 Participants
Participants with ccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort B: Non-clear Cell RCC (nccRCC)
n=165 Participants
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
|---|---|---|
|
Objective Response Rate (ORR)
|
36.4 Percentage of Participants
Interval 27.4 to 46.1
|
26.7 Percentage of Participants
Interval 20.1 to 34.1
|
SECONDARY outcome
Timeframe: Up to approximately 66 monthsPopulation: All allocated participants who received at least one dose of study treatment and had confirmed complete response or partial response.
For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.
Outcome measures
| Measure |
Cohort A: Clear Cell RCC (ccRCC)
n=40 Participants
Participants with ccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort B: Non-clear Cell RCC (nccRCC)
n=44 Participants
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
|---|---|---|
|
Duration of Response (DOR)
|
18.9 Months
Interval 2.3 to
NA=DOR upper limit not reached at time of data cut-off due to insufficient number of responding participants with PD
|
29.0 Months
Interval 2.8 to
NA=DOR upper limit not reached at time of data cut-off due to insufficient number of responding participants with PD
|
SECONDARY outcome
Timeframe: Up to approximately 66 monthsPopulation: All allocated participants who received at least one dose of study treatment.
DCR is defined as the percentage of participants who have achieved CR, PR, or Stable Disease (SD) for at least 6 months based on assessments by the BICR per RECIST 1.1. CR is defined as disappearance of all target lesions, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.
Outcome measures
| Measure |
Cohort A: Clear Cell RCC (ccRCC)
n=110 Participants
Participants with ccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort B: Non-clear Cell RCC (nccRCC)
n=165 Participants
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
|---|---|---|
|
Disease Control Rate (DCR)
|
58.2 Percentage of Participants
Interval 48.4 to 67.5
|
43.0 Percentage of Participants
Interval 35.4 to 51.0
|
SECONDARY outcome
Timeframe: Up to approximately 66 monthsPopulation: All allocated participants who received at least one dose of study treatment
PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
Outcome measures
| Measure |
Cohort A: Clear Cell RCC (ccRCC)
n=110 Participants
Participants with ccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort B: Non-clear Cell RCC (nccRCC)
n=165 Participants
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
|---|---|---|
|
Progression-free Survival (PFS)
|
7.1 Months
Interval 5.6 to 11.0
|
4.2 Months
Interval 2.9 to 5.6
|
SECONDARY outcome
Timeframe: Up to approximately 66 monthsPopulation: All allocated participants who received at least one dose of study treatment
OS was defined as the time from first dose of study treatment to death due to any cause
Outcome measures
| Measure |
Cohort A: Clear Cell RCC (ccRCC)
n=110 Participants
Participants with ccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort B: Non-clear Cell RCC (nccRCC)
n=165 Participants
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
|---|---|---|
|
Overall Survival
|
40.7 Months
Interval 31.1 to 52.6
|
29.9 Months
Interval 24.3 to 37.4
|
SECONDARY outcome
Timeframe: Up to approximately 27 monthsPopulation: All allocated participants who received at least one dose of study treatment
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Outcome measures
| Measure |
Cohort A: Clear Cell RCC (ccRCC)
n=110 Participants
Participants with ccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort B: Non-clear Cell RCC (nccRCC)
n=165 Participants
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
109 Participants
|
155 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: All allocated participants who received at least one dose of study treatment
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Outcome measures
| Measure |
Cohort A: Clear Cell RCC (ccRCC)
n=110 Participants
Participants with ccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort B: Non-clear Cell RCC (nccRCC)
n=165 Participants
Participants with nccRCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE
|
23 Participants
|
25 Participants
|
Adverse Events
Cohort A: ccRCC First Course
Serious events: 52 serious events
Other events: 105 other events
Deaths: 71 deaths
Cohort B: nccRCC First Course
Serious events: 47 serious events
Other events: 142 other events
Deaths: 113 deaths
Cohort A: ccRCC Second Course
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B: nccRCC Second Course
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: ccRCC First Course
n=110 participants at risk
Participants with clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort B: nccRCC First Course
n=165 participants at risk
Participants with non-clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort A: ccRCC Second Course
n=3 participants at risk
Participants with clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with ccRCC who experienced disease progression received up to 17 additional doses of pembrolizumab.
|
Cohort B: nccRCC Second Course
n=5 participants at risk
Participants with non-clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with nccRCC who experienced disease progression received up to 17 additional doses of pembrolizumab.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.8%
2/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Atrial fibrillation
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Cardiac failure
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.2%
2/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Pericardial effusion
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Pericarditis
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Colitis
|
3.6%
4/110 • Number of events 4 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.8%
3/165 • Number of events 3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
4/110 • Number of events 6 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Ileus
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Asthenia
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Chest pain
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
General physical health deterioration
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Pyrexia
|
1.8%
2/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Stent-graft endoleak
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.2%
2/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
2/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.91%
1/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Hepatitis
|
1.8%
2/110 • Number of events 3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Immune system disorders
Contrast media allergy
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Bronchitis
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Cellulitis
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Encephalitis
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Influenza
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Pneumonia
|
1.8%
2/110 • Number of events 3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.2%
2/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Sepsis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
2/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
2/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.7%
3/110 • Number of events 3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.2%
2/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.91%
1/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.2%
2/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Bell's palsy
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Cerebral infarction
|
1.8%
2/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Encephalopathy
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Lacunar infarction
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Myasthenic syndrome
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Myelopathy
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Seizure
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Product Issues
Device dislocation
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
2/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.2%
2/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.91%
1/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.2%
2/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.8%
3/165 • Number of events 3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.2%
2/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
2/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Vascular disorders
Hypotension
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
Other adverse events
| Measure |
Cohort A: ccRCC First Course
n=110 participants at risk
Participants with clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort B: nccRCC First Course
n=165 participants at risk
Participants with non-clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months).
|
Cohort A: ccRCC Second Course
n=3 participants at risk
Participants with clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with ccRCC who experienced disease progression received up to 17 additional doses of pembrolizumab.
|
Cohort B: nccRCC Second Course
n=5 participants at risk
Participants with non-clear cell RCC received pembrolizumab 200 mg IV Q3W for up to 35 doses (approximately 24 months). Eligible participants with nccRCC who experienced disease progression received up to 17 additional doses of pembrolizumab.
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
7.3%
8/110 • Number of events 8 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.3%
17/165 • Number of events 21 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
1/5 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.6%
15/110 • Number of events 16 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
11.5%
19/165 • Number of events 24 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Cardiac disorders
Tachycardia
|
0.91%
1/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
1/5 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
5.5%
6/110 • Number of events 6 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
11/165 • Number of events 11 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Endocrine disorders
Hypothyroidism
|
14.5%
16/110 • Number of events 17 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
15.8%
26/165 • Number of events 27 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
10/110 • Number of events 11 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
13.3%
22/165 • Number of events 28 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Constipation
|
20.9%
23/110 • Number of events 23 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.9%
18/165 • Number of events 23 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.8%
35/110 • Number of events 58 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
24.2%
40/165 • Number of events 65 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Dry mouth
|
11.8%
13/110 • Number of events 16 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
9.1%
15/165 • Number of events 18 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
8/110 • Number of events 8 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
3.6%
6/165 • Number of events 6 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
1/5 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
22/110 • Number of events 26 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
17.0%
28/165 • Number of events 38 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
8/110 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
16.4%
27/165 • Number of events 37 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Asthenia
|
11.8%
13/110 • Number of events 23 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
11.5%
19/165 • Number of events 22 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
1/5 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Catheter site pain
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.2%
2/165 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Chest pain
|
6.4%
7/110 • Number of events 7 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.5%
9/165 • Number of events 10 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Fatigue
|
39.1%
43/110 • Number of events 51 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
25.5%
42/165 • Number of events 48 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Influenza like illness
|
9.1%
10/110 • Number of events 24 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
4.2%
7/165 • Number of events 13 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Oedema peripheral
|
7.3%
8/110 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
8.5%
14/165 • Number of events 16 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/110 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/165 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
8/110 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
11/165 • Number of events 16 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Sinusitis
|
5.5%
6/110 • Number of events 7 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.8%
3/165 • Number of events 3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
9/110 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.5%
9/165 • Number of events 10 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
1/5 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Urinary tract infection
|
4.5%
5/110 • Number of events 15 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
8.5%
14/165 • Number of events 15 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
1/5 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
15/110 • Number of events 15 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
9.1%
15/165 • Number of events 17 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
10.9%
12/110 • Number of events 15 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
7.3%
12/165 • Number of events 13 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.3%
8/110 • Number of events 8 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
7.9%
13/165 • Number of events 15 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Blood creatinine increased
|
17.3%
19/110 • Number of events 23 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
7.3%
12/165 • Number of events 15 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Lymphocyte count decreased
|
6.4%
7/110 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
3.0%
5/165 • Number of events 11 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Neutrophil count decreased
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.8%
3/165 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Weight decreased
|
3.6%
4/110 • Number of events 4 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.1%
10/165 • Number of events 10 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
22/110 • Number of events 24 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
15.2%
25/165 • Number of events 29 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.4%
7/110 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.8%
3/165 • Number of events 3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.4%
7/110 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
1.8%
3/165 • Number of events 3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.3%
8/110 • Number of events 18 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
4.2%
7/165 • Number of events 10 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.6%
37/110 • Number of events 54 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
17.6%
29/165 • Number of events 40 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.9%
12/110 • Number of events 13 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
13.3%
22/165 • Number of events 28 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.91%
1/110 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
11/110 • Number of events 12 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.1%
10/165 • Number of events 15 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
7/110 • Number of events 7 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
9.1%
15/165 • Number of events 15 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Dizziness
|
9.1%
10/110 • Number of events 13 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
3.6%
6/165 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Headache
|
11.8%
13/110 • Number of events 17 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.9%
18/165 • Number of events 24 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Psychiatric disorders
Depression
|
7.3%
8/110 • Number of events 8 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
3.6%
6/165 • Number of events 7 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Psychiatric disorders
Insomnia
|
9.1%
10/110 • Number of events 13 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
7.9%
13/165 • Number of events 14 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Renal and urinary disorders
Haematuria
|
5.5%
6/110 • Number of events 6 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
3.6%
6/165 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.7%
25/110 • Number of events 30 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
15.8%
26/165 • Number of events 30 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.5%
16/110 • Number of events 19 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
9.1%
15/165 • Number of events 19 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.8%
2/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.5%
9/165 • Number of events 11 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.8%
2/110 • Number of events 2 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.61%
1/165 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.4%
7/110 • Number of events 9 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.1%
10/165 • Number of events 11 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.3%
41/110 • Number of events 54 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
22.4%
37/165 • Number of events 48 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
1/5 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.5%
17/110 • Number of events 23 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
11.5%
19/165 • Number of events 24 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.3%
8/110 • Number of events 8 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.1%
10/165 • Number of events 11 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Vascular disorders
Hypertension
|
8.2%
9/110 • Number of events 11 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
11/165 • Number of events 12 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/3 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/5 • Up to approximately 66 months
The safety analysis population includes all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Therefore, MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 18006726372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER