Trial Outcomes & Findings for Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (NCT NCT05287113)
NCT ID: NCT05287113
Last Updated: 2026-03-27
Results Overview
PFS was defined as the time from the date of randomization to the date of the first documented progression, as determined by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death due to any cause, whichever occurred first.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
176 participants
Primary outcome timeframe
up to 738 days
Results posted on
2026-03-27
Participant Flow
This study was conducted at 49 sites in Canada, Spain, France, Georgia, Greece, Italy, South Korea, Portugal, Taiwan, and the United States. Data collected through 28 January 2025 have been reported.
Participant milestones
| Measure |
Retifanlimab
Participants received retifanlimab on Day 1 in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02385 and INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385 Plus INCAGN02390
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) plus INCAGN02390 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met.
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
57
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
59
|
60
|
57
|
Reasons for withdrawal
| Measure |
Retifanlimab
Participants received retifanlimab on Day 1 in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02385 and INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385 Plus INCAGN02390
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) plus INCAGN02390 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met.
|
|---|---|---|---|
|
Overall Study
Death
|
22
|
23
|
28
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
4
|
|
Overall Study
Ongoing
|
35
|
32
|
24
|
Baseline Characteristics
Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Retifanlimab
n=59 Participants
Participants received retifanlimab on Day 1 in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02385 and INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385
n=60 Participants
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385 Plus INCAGN02390
n=57 Participants
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) plus INCAGN02390 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.85 years
STANDARD_DEVIATION 9.036 • n=56 Participants
|
65.48 years
STANDARD_DEVIATION 8.957 • n=62 Participants
|
62.14 years
STANDARD_DEVIATION 10.199 • n=123 Participants
|
64.19 years
STANDARD_DEVIATION 9.459 • n=53 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=56 Participants
|
9 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
29 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=56 Participants
|
51 Participants
n=62 Participants
|
50 Participants
n=123 Participants
|
147 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=56 Participants
|
2 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
5 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=56 Participants
|
57 Participants
n=62 Participants
|
51 Participants
n=123 Participants
|
162 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
9 Participants
n=53 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=56 Participants
|
17 Participants
n=62 Participants
|
17 Participants
n=123 Participants
|
48 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
4 Participants
n=53 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=56 Participants
|
40 Participants
n=62 Participants
|
34 Participants
n=123 Participants
|
114 Participants
n=53 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=56 Participants
|
3 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
10 Participants
n=53 Participants
|
PRIMARY outcome
Timeframe: up to 738 daysPopulation: Intent-to-Treat (ITT) Analysis Set: all randomized participants. Treatment groups were determined according to the treatment they were assigned at the time of randomization. Median PFS was estimated using the Kaplan-Meier method. The 95% confidence interval for median PFS was calculated using the generalization of Brookmeyer and Crowley method with log-log transformation.
PFS was defined as the time from the date of randomization to the date of the first documented progression, as determined by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death due to any cause, whichever occurred first.
Outcome measures
| Measure |
Retifanlimab
n=59 Participants
Participants received retifanlimab on Day 1 in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02385 and INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385
n=60 Participants
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385 Plus INCAGN02390
n=57 Participants
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) plus INCAGN02390 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met.
|
|---|---|---|---|
|
Progeression-free Survival (PFS)
|
5.6 months
Interval 3.5 to 9.7
|
5.8 months
Interval 3.7 to 7.6
|
5.3 months
Interval 2.1 to 7.9
|
SECONDARY outcome
Timeframe: up to approximately 44 monthsObjective response was defined as having a complete response (CR) or partial response (PR), determined based on investigator assessment per RECIST v1.1, recorded post-baseline before and including the first progressive disease, and before new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to approximately 44 monthsDOR was defined as the time from earliest date of disease response (CR or PR) until the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death from any cause if occurring sooner than progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to approximately 44 monthsDisease control was defined as having CR, PR, or stable disease (SD) as best response on or after Day 180, based on investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to approximately 44 monthsOverall survival was defined as the time from the date of randomization to the date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to approximately 44 monthsAdverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 90 days of the last administration of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to approximately 44 monthsAEs were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 90 days of the last administration of study drug.
Outcome measures
Outcome data not reported
Adverse Events
Retifanlimab
Serious events: 24 serious events
Other events: 52 other events
Deaths: 22 deaths
Retifanlimab Plus INCAGN02385
Serious events: 20 serious events
Other events: 51 other events
Deaths: 23 deaths
Retifanlimab Plus INCAGN02385 Plus INCAGN02390
Serious events: 27 serious events
Other events: 51 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Retifanlimab
n=58 participants at risk
Participants received retifanlimab on Day 1 in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02385 and INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385
n=60 participants at risk
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385 Plus INCAGN02390
n=57 participants at risk
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) plus INCAGN02390 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
General disorders
Asthenia
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Nervous system disorders
Autoimmune encephalopathy
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
COVID-19
|
3.4%
2/58 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
General disorders
Death
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Product Issues
Device dislocation
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Device related infection
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Empyema
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
General disorders
Fatigue
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Gastric perforation
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
General disorders
General physical health deterioration
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Nervous system disorders
Headache
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal fistula
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Pneumonia
|
8.6%
5/58 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
12.3%
7/57 • Number of events 7 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Refeeding syndrome
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Nervous system disorders
Sensory loss
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Sepsis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Nervous system disorders
Syncope
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Nervous system disorders
Tremor
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
6.9%
4/58 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour obstruction
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
Other adverse events
| Measure |
Retifanlimab
n=58 participants at risk
Participants received retifanlimab on Day 1 in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02385 and INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385
n=60 participants at risk
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met. Participants also received placebo matching INCAGN02390 on Days 1 and 15 of each 4-week cycle.
|
Retifanlimab Plus INCAGN02385 Plus INCAGN02390
n=57 participants at risk
Participants received retifanlimab (on Day 1) plus INCAGN02385 (on Days 1 and 15) plus INCAGN02390 (on Days 1 and 15) in 4-week cycles for up to 2 years or until discontinuation criteria were met.
|
|---|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.8%
5/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
6/58 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.9%
4/58 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Alanine aminotransferase increased
|
6.9%
4/58 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Amylase increased
|
12.1%
7/58 • Number of events 13 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.4%
13/58 • Number of events 14 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
26.7%
16/60 • Number of events 21 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
17.5%
10/57 • Number of events 11 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Psychiatric disorders
Anxiety
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
5/58 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.0%
6/60 • Number of events 7 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.8%
5/57 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Aspartate aminotransferase increased
|
10.3%
6/58 • Number of events 8 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.0%
6/60 • Number of events 7 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
14.0%
8/57 • Number of events 9 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
General disorders
Asthenia
|
12.1%
7/58 • Number of events 7 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.3%
5/60 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.8%
5/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
5/58 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.3%
6/58 • Number of events 7 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.3%
5/60 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Blood bilirubin increased
|
5.2%
3/58 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Blood creatinine increased
|
6.9%
4/58 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
14.0%
8/57 • Number of events 13 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
6.7%
4/60 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
COVID-19
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Constipation
|
17.2%
10/58 • Number of events 10 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
15.8%
9/57 • Number of events 11 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.5%
9/58 • Number of events 11 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.0%
6/60 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.5%
6/57 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.3%
6/58 • Number of events 7 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.0%
6/60 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.8%
5/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.0%
11/58 • Number of events 18 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
15.0%
9/60 • Number of events 12 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
15.8%
9/57 • Number of events 11 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Nervous system disorders
Dizziness
|
5.2%
3/58 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.8%
5/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Eye disorders
Dry eye
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Dry mouth
|
10.3%
6/58 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.8%
5/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Nervous system disorders
Dysgeusia
|
3.4%
2/58 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Dysphagia
|
13.8%
8/58 • Number of events 8 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.0%
6/60 • Number of events 7 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.5%
6/57 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.3%
6/58 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
General disorders
Fatigue
|
17.2%
10/58 • Number of events 10 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
16.7%
10/60 • Number of events 11 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
19.3%
11/57 • Number of events 12 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.4%
2/58 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.0%
6/60 • Number of events 9 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Nervous system disorders
Headache
|
13.8%
8/58 • Number of events 11 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.3%
5/60 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.8%
5/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
6.7%
4/60 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.5%
6/57 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.9%
4/58 • Number of events 10 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 10 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Vascular disorders
Hypertension
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
6.7%
4/60 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.8%
5/57 • Number of events 7 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Endocrine disorders
Hyperthyroidism
|
8.6%
5/58 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
6.7%
4/60 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.3%
5/60 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.9%
4/58 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.0%
6/60 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.4%
2/58 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.5%
9/58 • Number of events 17 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
15.0%
9/60 • Number of events 13 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
12.3%
7/57 • Number of events 11 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.9%
4/58 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
12.3%
7/57 • Number of events 8 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Vascular disorders
Hypotension
|
3.4%
2/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Endocrine disorders
Hypothyroidism
|
15.5%
9/58 • Number of events 10 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
21.7%
13/60 • Number of events 13 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
31.6%
18/57 • Number of events 19 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Psychiatric disorders
Insomnia
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.5%
6/57 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.9%
4/58 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Lipase increased
|
12.1%
7/58 • Number of events 15 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 9 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Lymphocyte count decreased
|
3.4%
2/58 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.4%
2/58 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.2%
3/58 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.9%
4/58 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Nausea
|
15.5%
9/58 • Number of events 14 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
11.7%
7/60 • Number of events 8 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.8%
5/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
6.7%
4/60 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Odynophagia
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
General disorders
Oedema peripheral
|
8.6%
5/58 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
6.7%
4/60 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Oral candidiasis
|
3.4%
2/58 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Oral pain
|
5.2%
3/58 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.3%
6/58 • Number of events 9 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
4/58 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.3%
2/60 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.7%
1/58 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Pneumonia
|
5.2%
3/58 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.0%
3/60 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.1%
7/58 • Number of events 7 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.8%
8/58 • Number of events 9 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.3%
5/60 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.5%
6/57 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/58 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
General disorders
Pyrexia
|
10.3%
6/58 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.0%
6/60 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
16.7%
10/60 • Number of events 11 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.5%
6/57 • Number of events 8 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.2%
3/58 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Infections and infestations
Respiratory tract infection
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/57 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.2%
3/58 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.8%
1/57 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Stomatitis
|
15.5%
9/58 • Number of events 11 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Troponin increased
|
8.6%
5/58 • Number of events 5 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
8.3%
5/60 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
5.3%
3/57 • Number of events 3 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
8.6%
5/58 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
0.00%
0/60 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 2 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
3/58 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
6.7%
4/60 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
7.0%
4/57 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
Weight decreased
|
6.9%
4/58 • Number of events 4 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
13.3%
8/60 • Number of events 9 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
10.5%
6/57 • Number of events 6 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
|
Investigations
White blood cell count decreased
|
5.2%
3/58 • Number of events 7 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
1.7%
1/60 • Number of events 1 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
3.5%
2/57 • Number of events 13 • up to 828 days
Adverse events are reported for the Safety Population, comprised of all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of assigned treatment at the time of randomization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER