Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164) (NCT NCT02460198)
NCT ID: NCT02460198
Last Updated: 2023-07-27
Results Overview
Objective response rate was defined as the percentage of the participants in the analysis population who had a complete response (CR) or partial response (PR). Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. The point estimate and 95% confidence interval for the ORR, were provided using an exact binomial distribution (Clopper and Pearson method). Participants without response data were counted as nonresponders. The data cutoff date was 09-SEPT-2019.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Up to approximately 48 months
Results posted on
2023-07-27
Participant Flow
This study was conducted at 34 clinical sites in 10 countries.
Participant flow as per the database cutoff date of 19FEB2021.
Participant milestones
| Measure |
Cohort A - Pembrolizumab 200 mg
Participants were previously treated with standard therapies, which included fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
|
Cohort B - Pembrolizumab 200 mg
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
63
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
61
|
63
|
Reasons for withdrawal
| Measure |
Cohort A - Pembrolizumab 200 mg
Participants were previously treated with standard therapies, which included fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
|
Cohort B - Pembrolizumab 200 mg
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Death
|
36
|
28
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Transferred to Extension Study
|
15
|
15
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Site Terminated By Sponsor
|
0
|
1
|
|
Overall Study
Did Not Continue on Extension Study
|
6
|
11
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
Baseline characteristics by cohort
| Measure |
Cohort A - Pembrolizumab 200 mg
n=61 Participants
Participants were previously treated with standard therapies, which included fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
|
Cohort B - Pembrolizumab 200 mg
n=63 Participants
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 52 cycles (up to approximately 3 years), which included a first course of 35 cycles and second course treatment phase of 17 cycles after experiencing PD if criteria were met for re-treatment.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 Years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
57.8 Years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
56.1 Years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 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
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 48 monthsPopulation: The analysis population consisted of all participants who received at least one dose of study treatment.
Objective response rate was defined as the percentage of the participants in the analysis population who had a complete response (CR) or partial response (PR). Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. The point estimate and 95% confidence interval for the ORR, were provided using an exact binomial distribution (Clopper and Pearson method). Participants without response data were counted as nonresponders. The data cutoff date was 09-SEPT-2019.
Outcome measures
| Measure |
Cohort A - Pembrolizumab 200 mg
n=61 Participants
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort B - Pembrolizumab 200 mg
n=63 Participants
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
|
|---|---|---|
|
Objective Response Rate (ORR) - Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) Assessed by Central Imaging Vendor
|
32.8 Percentage of participants
Interval 21.3 to 46.0
|
34.9 Percentage of participants
Interval 23.3 to 48.0
|
SECONDARY outcome
Timeframe: Up to approximately 66 monthsPopulation: The analysis population consisted of all participants who received at least one dose of study treatment.
Disease Control Rate was defined as the percentage of participants who achieved confirmed CR or PR or had demonstrated stable disease (SD) for at least 24 weeks prior to any evidence of progression. Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. or the appearance of new lesion(s). Participants in the analysis population with missing DCR were considered as disease not under control. The data cutoff date was 19-Feb-2021.
Outcome measures
| Measure |
Cohort A - Pembrolizumab 200 mg
n=61 Participants
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort B - Pembrolizumab 200 mg
n=63 Participants
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
|
|---|---|---|
|
Disease Control Rate (DCR) Per RECIST 1.1 Assessed by Central Imaging Vendor.
|
50.8 Percentage of participants
Interval 37.7 to 63.9
|
55.6 Percentage of participants
Interval 42.5 to 68.1
|
SECONDARY outcome
Timeframe: Up to approximately 66 monthsPopulation: The analysis population consisted of all participants who received at least one dose of study treatment.
PFS is defined as the time from first day of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression). PFS was summarized by Kaplan-Meier (KM) methods. The data cutoff date was 19-FEB-2021.
Outcome measures
| Measure |
Cohort A - Pembrolizumab 200 mg
n=61 Participants
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort B - Pembrolizumab 200 mg
n=63 Participants
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
|
|---|---|---|
|
Progression-Free Survival (PFS) Per RECIST 1.1 Assessed by Central Imaging Vendor.
|
2.3 Months
Interval 2.1 to 8.1
|
4.1 Months
Interval 2.1 to 18.9
|
SECONDARY outcome
Timeframe: Up to approximately 66 monthsPopulation: The analysis population consisted of all participants who received at least one dose of study treatment.
OS is defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of analysis are censored at the date of the last follow-up. OS was summarized by Kaplan-Meier (KM) methods. The data cutoff date was 19-FEB-2021.
Outcome measures
| Measure |
Cohort A - Pembrolizumab 200 mg
n=61 Participants
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort B - Pembrolizumab 200 mg
n=63 Participants
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
|
|---|---|---|
|
Overall Survival (OS)
|
31.4 Months
Interval 21.4 to 58.0
|
47 Months
Interval 19.2 to
NA = OS upper limit was not reached (insufficient number of deaths by time of last disease assessment).
|
SECONDARY outcome
Timeframe: Up to approximately 66 monthsPopulation: The analysis population consisted of all participants who received at least one dose of study treatment.
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Outcome measures
| Measure |
Cohort A - Pembrolizumab 200 mg
n=61 Participants
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort B - Pembrolizumab 200 mg
n=63 Participants
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE).
|
60 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 36 monthsPopulation: The analysis population consisted of all participants who received at least one dose of study treatment.
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Outcome measures
| Measure |
Cohort A - Pembrolizumab 200 mg
n=61 Participants
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort B - Pembrolizumab 200 mg
n=63 Participants
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE.
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 66 monthsPopulation: The analysis population consisted of all participants who received at least one dose of study treatment and demonstrated a CR or PR.
For participants who demonstrated a CR or PR, duration of response was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. Duration of Response was based on Independent radiologist review (IRC) using RECIST 1.1 and was summarized by Kaplan-Meier (KM) methods for censored data. Nonresponders were excluded from the analysis of DOR.
Outcome measures
| Measure |
Cohort A - Pembrolizumab 200 mg
n=20 Participants
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort B - Pembrolizumab 200 mg
n=22 Participants
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
|
|---|---|---|
|
Duration of Response (DOR) Per RECIST 1.1 as Assessed by the Central Imaging Vendor
|
NA Months
Interval 6.2 to
NA = Median DOR and DOR upper limit were not reached by the time of last disease assessment.
|
NA Months
Interval 4.4 to
NA = Median DOR and DOR upper limit were not reached by the time of last disease assessment.
|
Adverse Events
Cohort A First Course
Serious events: 31 serious events
Other events: 56 other events
Deaths: 38 deaths
Cohort B First Course
Serious events: 25 serious events
Other events: 58 other events
Deaths: 31 deaths
Cohort A Second Course
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort B Second Course
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A First Course
n=61 participants at risk
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort B First Course
n=63 participants at risk
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort A Second Course
n=6 participants at risk
Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.
|
Cohort B Second Course
n=3 participants at risk
Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Cardiac disorders
Acute myocardial infarction
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Cardiac disorders
Sinus bradycardia
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Eye disorders
Cataract
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Eye disorders
Corneal decompensation
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
3/61 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Colitis
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Enteritis
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Ileus
|
4.9%
3/61 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Pancreatitis
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Subileus
|
1.6%
1/61 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
Euthanasia
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
General physical health deterioration
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
Generalised oedema
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
Pyrexia
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Hepatobiliary disorders
Biloma
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Bronchitis
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Device related infection
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Influenza
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Pneumonia
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Sepsis
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
6.3%
4/63 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Urinary tract infection
|
3.3%
2/61 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Urosepsis
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Investigations
Blood bilirubin increased
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Metabolism and nutrition disorders
Alkalosis hypochloraemic
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Nervous system disorders
Headache
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Nervous system disorders
Paralysis
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Nervous system disorders
Syncope
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Product Issues
Device breakage
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Psychiatric disorders
Suicide attempt
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.6%
1/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
6.3%
4/63 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.6%
1/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Vascular disorders
Embolism
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Vascular disorders
Iliac artery occlusion
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
Other adverse events
| Measure |
Cohort A First Course
n=61 participants at risk
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort B First Course
n=63 participants at risk
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
|
Cohort A Second Course
n=6 participants at risk
Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.
|
Cohort B Second Course
n=3 participants at risk
Participants who completed first course of treatment were treated with pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 17 cycles (approximately 1 year) after experiencing PD if criteria were met for re-treatment.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.7%
12/61 • Number of events 21 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
17.5%
11/63 • Number of events 13 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
2/6 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Ear and labyrinth disorders
Tinnitus
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Endocrine disorders
Hyperthyroidism
|
6.6%
4/61 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
11.1%
7/63 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Endocrine disorders
Hypothyroidism
|
9.8%
6/61 • Number of events 6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
20.6%
13/63 • Number of events 15 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Eye disorders
Dry eye
|
6.6%
4/61 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.6%
4/61 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Abdominal distension
|
6.6%
4/61 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Abdominal pain
|
29.5%
18/61 • Number of events 26 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
22.2%
14/63 • Number of events 18 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Colitis
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Constipation
|
21.3%
13/61 • Number of events 15 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
20.6%
13/63 • Number of events 14 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Diarrhoea
|
37.7%
23/61 • Number of events 46 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
25.4%
16/63 • Number of events 28 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
5/61 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
14.3%
9/63 • Number of events 9 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Nausea
|
36.1%
22/61 • Number of events 32 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
27.0%
17/63 • Number of events 26 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Proctalgia
|
3.3%
2/61 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Stomatitis
|
4.9%
3/61 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Toothache
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Gastrointestinal disorders
Vomiting
|
29.5%
18/61 • Number of events 37 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
22.2%
14/63 • Number of events 18 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
Asthenia
|
23.0%
14/61 • Number of events 20 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
7.9%
5/63 • Number of events 6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
Chills
|
4.9%
3/61 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
6.3%
4/63 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
Fatigue
|
31.1%
19/61 • Number of events 24 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
38.1%
24/63 • Number of events 29 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
Influenza like illness
|
6.6%
4/61 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
11.1%
7/63 • Number of events 11 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
Malaise
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
Oedema peripheral
|
18.0%
11/61 • Number of events 12 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
15.9%
10/63 • Number of events 10 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
General disorders
Pyrexia
|
21.3%
13/61 • Number of events 22 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
17.5%
11/63 • Number of events 19 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
2/6 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Conjunctivitis
|
6.6%
4/61 • Number of events 6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Enterocolitis infectious
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Folliculitis
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Gingivitis
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Groin abscess
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Nasopharyngitis
|
11.5%
7/61 • Number of events 9 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Sinusitis
|
6.6%
4/61 • Number of events 8 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Upper respiratory tract infection
|
13.1%
8/61 • Number of events 13 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
12.7%
8/63 • Number of events 10 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Urinary tract infection
|
6.6%
4/61 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
7.9%
5/63 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Infections and infestations
Wound infection
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Injury, poisoning and procedural complications
Stoma site pruritus
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Investigations
Alanine aminotransferase increased
|
13.1%
8/61 • Number of events 11 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
11.1%
7/63 • Number of events 10 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Investigations
Aspartate aminotransferase increased
|
9.8%
6/61 • Number of events 9 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
7.9%
5/63 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Investigations
Blood alkaline phosphatase increased
|
8.2%
5/61 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Investigations
Blood bilirubin increased
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
6.3%
4/63 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Investigations
Blood creatinine increased
|
8.2%
5/61 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Investigations
Weight decreased
|
11.5%
7/61 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.0%
14/61 • Number of events 16 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
17.5%
11/63 • Number of events 13 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
2/6 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.2%
5/61 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
9.5%
6/63 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.9%
3/61 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
6.3%
4/63 • Number of events 14 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.3%
2/61 • Number of events 12 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.6%
15/61 • Number of events 26 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
25.4%
16/63 • Number of events 19 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.1%
8/61 • Number of events 8 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
22.2%
14/63 • Number of events 18 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.9%
3/61 • Number of events 9 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.6%
4/61 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.8%
6/61 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
11.1%
7/63 • Number of events 7 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
5/61 • Number of events 6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
7.9%
5/63 • Number of events 8 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Nervous system disorders
Amnesia
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Nervous system disorders
Dizziness
|
6.6%
4/61 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
4.8%
3/63 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Nervous system disorders
Dysgeusia
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Nervous system disorders
Headache
|
14.8%
9/61 • Number of events 11 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
12.7%
8/63 • Number of events 16 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Nervous system disorders
Neuropathy peripheral
|
6.6%
4/61 • Number of events 6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Nervous system disorders
Paraesthesia
|
3.3%
2/61 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Psychiatric disorders
Depression
|
3.3%
2/61 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
7.9%
5/63 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Psychiatric disorders
Drug dependence
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Psychiatric disorders
Insomnia
|
13.1%
8/61 • Number of events 8 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
7.9%
5/63 • Number of events 6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Renal and urinary disorders
Dysuria
|
6.6%
4/61 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Renal and urinary disorders
Haematuria
|
3.3%
2/61 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Renal and urinary disorders
Urinary tract discomfort
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/63 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.6%
15/61 • Number of events 20 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
14.3%
9/63 • Number of events 9 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.8%
9/61 • Number of events 10 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
12.7%
8/63 • Number of events 9 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/61 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
7.9%
5/63 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.9%
3/61 • Number of events 3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
6.3%
4/63 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.6%
4/61 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.6%
4/61 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
7.9%
5/63 • Number of events 8 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
7.9%
5/63 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.0%
11/61 • Number of events 15 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
12.7%
8/63 • Number of events 9 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.1%
8/61 • Number of events 13 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
14.3%
9/63 • Number of events 18 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
6.3%
4/63 • Number of events 5 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/61 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
1.6%
1/63 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
33.3%
1/3 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.3%
2/61 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
3.2%
2/63 • Number of events 2 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
16.7%
1/6 • Number of events 1 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
|
Vascular disorders
Hypertension
|
6.6%
4/61 • Number of events 4 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
7.9%
5/63 • Number of events 9 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/6 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
0.00%
0/3 • Up to approximately 66 months
Adverse events were collected for a minimum of 30 days after the end of treatment and every 12 weeks during follow-up. The analysis population for AEs included all randomized participants who received at least one dose of study medication whereas the analysis population for deaths included all randomized participants. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression", and "Disease Progression" not related to the drug were excluded. Database Cutoff Date: 19FEB2021
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor 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. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER