Trial Outcomes & Findings for Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer (NCT NCT02200614)
NCT ID: NCT02200614
Last Updated: 2022-06-28
Results Overview
Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1509 participants
Primary outcome timeframe
From randomization to the time approximately 385 MFS events were observed (approximately 48 months)
Results posted on
2022-06-28
Participant Flow
Study was conducted at multiple centers in 36 countries between 12 September 2014 (first participant first visit) and 14 June 2021 (last participant last visit).
From 2696 participants who signed informed consent, 1187 participants were discontinued from screening. A total of 1509 participants were randomly assigned to either darolutamide arm or placebo arm. The study was unblinded on 30 OCT 2018 and participants in the placebo arm could cross over to open-label darolutamide treatment.
Participant milestones
| Measure |
Darolutamide (BAY1841788)
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Double Blind Treatment
STARTED
|
955
|
554
|
|
Double Blind Treatment
COMPLETED
|
591
|
170
|
|
Double Blind Treatment
NOT COMPLETED
|
364
|
384
|
|
Open Label
STARTED
|
591
|
170
|
|
Open Label
COMPLETED
|
295
|
114
|
|
Open Label
NOT COMPLETED
|
296
|
56
|
Reasons for withdrawal
| Measure |
Darolutamide (BAY1841788)
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Double Blind Treatment
Adverse Event
|
86
|
48
|
|
Double Blind Treatment
Confirmed metastasis
|
120
|
140
|
|
Double Blind Treatment
Judgment of the investigator
|
59
|
99
|
|
Double Blind Treatment
Metastasis by local reading
|
1
|
3
|
|
Double Blind Treatment
Other reason
|
6
|
2
|
|
Double Blind Treatment
Personal reason
|
77
|
85
|
|
Double Blind Treatment
Protocol deviation
|
14
|
7
|
|
Double Blind Treatment
Not treated
|
1
|
0
|
|
Open Label
Adverse Event
|
41
|
11
|
|
Open Label
Confirmed metastasis
|
1
|
0
|
|
Open Label
Judgment of the investigator
|
29
|
2
|
|
Open Label
Metastasis by local reading
|
138
|
27
|
|
Open Label
Other reason
|
22
|
4
|
|
Open Label
Personal reason
|
60
|
8
|
|
Open Label
Protocol deviation
|
3
|
2
|
|
Open Label
Missing
|
2
|
2
|
Baseline Characteristics
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Darolutamide (BAY1841788)
n=955 Participants
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
n=554 Participants
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
Total
n=1509 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.9 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
73.2 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
73.6 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
955 Participants
n=5 Participants
|
554 Participants
n=7 Participants
|
1509 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asia
|
122 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
760 Participants
n=5 Participants
|
434 Participants
n=7 Participants
|
1194 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
36 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the time approximately 385 MFS events were observed (approximately 48 months)Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)
Outcome measures
| Measure |
Darolutamide (BAY1841788)
n=955 Participants
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
n=554 Participants
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Metastasis-Free Survival
|
40.37 months
Interval 34.33 to
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
18.43 months
Interval 15.51 to 22.34
|
SECONDARY outcome
Timeframe: From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)Overall Survival (OS) was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Darolutamide (BAY1841788)
n=955 Participants
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
n=554 Participants
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Overall Survival - Primary Analysis
|
NA months
Interval 44.45 to
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
NA months
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.
Outcome measures
| Measure |
Darolutamide (BAY1841788)
n=955 Participants
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
n=554 Participants
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Time to Pain Progression - Primary Analysis
|
40.31 months
Interval 33.21 to 41.2
|
25.36 months
Interval 19.09 to 29.63
|
SECONDARY outcome
Timeframe: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.
Outcome measures
| Measure |
Darolutamide (BAY1841788)
n=955 Participants
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
n=554 Participants
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis
|
NA months
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
38.21 months
Interval 35.55 to 41.89
|
SECONDARY outcome
Timeframe: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.
Outcome measures
| Measure |
Darolutamide (BAY1841788)
n=955 Participants
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
n=554 Participants
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis
|
NA months
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
NA months
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)Overall Survival (OS) was defined as the time from randomization to death due to any cause. The final analysis was done at the time of the data cut-off (15 NOV 2019).
Outcome measures
| Measure |
Darolutamide (BAY1841788)
n=955 Participants
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
n=554 Participants
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Overall Survival - Final Analysis
|
NA months
Interval 56.14 to
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
NA months
Interval 46.91 to
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)For time to pain progression, the analysis performed using the primary completion cut-off data (03 SEP 2018) was considered final and no new analysis was performed for time to pain progression.
Outcome measures
| Measure |
Darolutamide (BAY1841788)
n=955 Participants
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
n=554 Participants
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Time to Pain Progression - Final Analysis
|
40.31 months
Interval 33.21 to 41.2
|
25.36 months
Interval 19.09 to 29.63
|
SECONDARY outcome
Timeframe: From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months)The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle. The final analysis was done at the time of the data cut-off (15 NOV 2019).
Outcome measures
| Measure |
Darolutamide (BAY1841788)
n=955 Participants
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
n=554 Participants
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis
|
NA months
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
NA months
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization until occurrence of first SSE event (approximately 59 months)The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).
Outcome measures
| Measure |
Darolutamide (BAY1841788)
n=955 Participants
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo
n=554 Participants
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|
|
Time to First Symptomatic Skeletal Event (SSE) - Final Analysis
|
NA months
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
NA months
NA = value cannot be estimated due to censored data, insufficient number of participants with events
|
Adverse Events
Darolutamide (DB)
Serious events: 251 serious events
Other events: 673 other events
Deaths: 155 deaths
Darolutamide (DB+OL)
Serious events: 367 serious events
Other events: 742 other events
Deaths: 224 deaths
Placebo (DB)
Serious events: 121 serious events
Other events: 354 other events
Deaths: 137 deaths
Placebo+Darolutamide (CO)
Serious events: 43 serious events
Other events: 110 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Darolutamide (DB)
n=954 participants at risk
Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg (double blind \[DB\]).
|
Darolutamide (DB+OL)
n=954 participants at risk
Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo (DB)
n=554 participants at risk
Participants received matching placebo 2 tablets twice daily with food (double blind \[DB\]).
|
Placebo+Darolutamide (CO)
n=170 participants at risk
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|---|---|
|
Infections and infestations
Urosepsis
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 10 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Acute endocarditis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Embolism
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Vestibular neuronitis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Wound infection
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Product Issues
Device dislocation
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Product Issues
Device occlusion
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Wound abscess
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Intervertebral discitis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Abdominal abscess
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Severe acute respiratory syndrome
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.31%
3/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.84%
8/954 • Number of events 9 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.52%
5/954 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.63%
6/954 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Angina pectoris
|
0.42%
4/954 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Angina unstable
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Aortic valve stenosis
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Arrhythmia
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Atrial fibrillation
|
0.84%
8/954 • Number of events 11 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.94%
9/954 • Number of events 12 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.54%
3/554 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Atrial flutter
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Atrioventricular block
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Atrioventricular block complete
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Urinary tract infection
|
0.73%
7/954 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.3%
12/954 • Number of events 13 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Bradycardia
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Cardiac arrest
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.54%
3/554 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Cardiac failure
|
0.84%
8/954 • Number of events 9 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.3%
12/954 • Number of events 14 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.72%
4/554 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Cardiac failure acute
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Conduction disorder
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Coronary artery disease
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Coronary artery occlusion
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Coronary artery stenosis
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Myocardial infarction
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
11/954 • Number of events 12 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Myocardial ischaemia
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Palpitations
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Cardiac disorder
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Aortic valve disease
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Sinus node dysfunction
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Ear and labyrinth disorders
Vertigo
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Eye disorders
Cataract
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Eye disorders
Glaucoma
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Eye disorders
Retinal detachment
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Eye disorders
Visual impairment
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Eye disorders
Macular hole
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Constipation
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Ileus
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Plicated tongue
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Proctitis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Rectal stenosis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Subileus
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Hiatus hernia, obstructive
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Asthenia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Chest pain
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Death
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.63%
6/954 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Gait disturbance
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Pyrexia
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Sudden death
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Sudden cardiac death
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
General physical health deterioration
|
0.52%
5/954 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.73%
7/954 • Number of events 11 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Hepatobiliary disorders
Cholestasis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Hepatobiliary disorders
Liver disorder
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Immune system disorders
Hypersensitivity
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Appendicitis
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Dengue fever
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Diverticulitis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Endocarditis
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Erysipelas
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Herpes zoster
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Influenza
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Meningitis bacterial
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Perinephric abscess
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Pneumonia
|
1.6%
15/954 • Number of events 18 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.1%
20/954 • Number of events 24 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.1%
6/554 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Pyelonephritis
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Pyelonephritis acute
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Sepsis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Septic shock
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Sialoadenitis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Tick-borne viral encephalitis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Cholecystitis infective
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Device related infection
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Varicella zoster virus infection
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Medical device site joint infection
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
COVID-19
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Fall
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Stenosis of vesicourethral anastomosis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Flatback syndrome
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Incarcerated parastomal hernia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Alanine aminotransferase increased
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Aspartate aminotransferase increased
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Biopsy prostate
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Body temperature increased
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Transaminases increased
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Urine output decreased
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Angiocardiogram
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Metabolism and nutrition disorders
Cachexia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.31%
3/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Rapidly progressive osteoarthritis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatic neoplasm
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.31%
3/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.31%
3/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Bulbar palsy
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Carotid artery stenosis
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Cerebral infarction
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Cerebral ischaemia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.63%
6/954 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.54%
3/554 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Dizziness
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Myelopathy
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Presyncope
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Seizure
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Syncope
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Brain oedema
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Perineurial cyst
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Cognitive disorder
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Ischaemic stroke
|
0.52%
5/954 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.52%
5/954 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Partial seizures
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Psychiatric disorders
Depression
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Psychiatric disorders
Major depression
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Calculus bladder
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Dysuria
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.54%
3/554 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Haematuria
|
1.2%
11/954 • Number of events 13 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.6%
25/954 • Number of events 29 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.3%
7/554 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.84%
8/954 • Number of events 10 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.72%
4/554 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Oliguria
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Renal colic
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Renal failure
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.72%
4/554 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
16/954 • Number of events 17 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.5%
33/954 • Number of events 37 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.6%
20/554 • Number of events 20 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.5%
6/170 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Urine flow decreased
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.73%
7/954 • Number of events 9 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
11/954 • Number of events 13 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.54%
3/554 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Renal impairment
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Urethral stenosis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.42%
4/954 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.73%
7/954 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.54%
3/554 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Reproductive system and breast disorders
Prostate induration
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.54%
3/554 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.54%
3/554 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.42%
4/954 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.52%
5/954 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.52%
5/954 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.73%
7/954 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Bladder catheterisation
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Orchidectomy
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Nephrostomy
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Artificial urinary sphincter implant
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Radiotherapy to brain
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Prostatectomy
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Surgical and medical procedures
Pulmonary resection
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Aortic dissection
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Aortic stenosis
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.31%
3/954 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Hypertension
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Hypotension
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Lymphoedema
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Peripheral ischaemia
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Thrombosis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.21%
2/954 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Iliac artery stenosis
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.10%
1/954 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
Other adverse events
| Measure |
Darolutamide (DB)
n=954 participants at risk
Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg (double blind \[DB\]).
|
Darolutamide (DB+OL)
n=954 participants at risk
Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
|
Placebo (DB)
n=554 participants at risk
Participants received matching placebo 2 tablets twice daily with food (double blind \[DB\]).
|
Placebo+Darolutamide (CO)
n=170 participants at risk
Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.3%
60/954 • Number of events 76 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
9.7%
93/954 • Number of events 136 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
5.1%
28/554 • Number of events 33 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.1%
7/170 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
13/954 • Number of events 17 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.2%
21/954 • Number of events 27 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.72%
4/554 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
19/954 • Number of events 20 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.7%
26/954 • Number of events 30 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.1%
6/554 • Number of events 8 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Eye disorders
Cataract
|
1.2%
11/954 • Number of events 11 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.6%
15/954 • Number of events 16 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.90%
5/554 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.4%
4/170 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
25/954 • Number of events 27 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.7%
35/954 • Number of events 39 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.2%
12/554 • Number of events 14 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
14/954 • Number of events 16 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.7%
16/954 • Number of events 19 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.5%
14/554 • Number of events 15 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Constipation
|
6.8%
65/954 • Number of events 70 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
8.8%
84/954 • Number of events 94 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
6.5%
36/554 • Number of events 41 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.7%
8/170 • Number of events 11 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
69/954 • Number of events 87 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
9.1%
87/954 • Number of events 114 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
6.0%
33/554 • Number of events 37 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
8.8%
15/170 • Number of events 16 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Nausea
|
5.6%
53/954 • Number of events 59 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
6.3%
60/954 • Number of events 76 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
5.8%
32/554 • Number of events 37 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.5%
6/170 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
17/954 • Number of events 19 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.2%
21/954 • Number of events 24 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
10/554 • Number of events 12 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Asthenia
|
3.9%
37/954 • Number of events 42 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.5%
43/954 • Number of events 53 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.6%
20/554 • Number of events 23 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.1%
7/170 • Number of events 8 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Fatigue
|
13.2%
126/954 • Number of events 164 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
14.9%
142/954 • Number of events 198 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
8.5%
47/554 • Number of events 60 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
5.3%
9/170 • Number of events 9 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Oedema peripheral
|
4.5%
43/954 • Number of events 49 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
6.0%
57/954 • Number of events 67 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.1%
17/554 • Number of events 19 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.4%
4/170 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
General disorders
Pyrexia
|
1.9%
18/954 • Number of events 25 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.2%
21/954 • Number of events 28 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.90%
5/554 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.9%
5/170 • Number of events 9 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Bronchitis
|
1.4%
13/954 • Number of events 17 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.4%
23/954 • Number of events 30 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.6%
9/554 • Number of events 10 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Influenza
|
2.9%
28/954 • Number of events 33 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.8%
36/954 • Number of events 42 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.4%
8/554 • Number of events 8 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
39/954 • Number of events 50 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
5.9%
56/954 • Number of events 78 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.2%
23/554 • Number of events 27 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.7%
8/170 • Number of events 11 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Pneumonia
|
1.0%
10/954 • Number of events 11 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.3%
22/954 • Number of events 24 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.90%
5/554 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
26/954 • Number of events 29 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.6%
34/954 • Number of events 40 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
10/554 • Number of events 13 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
Urinary tract infection
|
4.6%
44/954 • Number of events 59 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
7.7%
73/954 • Number of events 130 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
5.6%
31/554 • Number of events 37 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
7.1%
12/170 • Number of events 12 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Infections and infestations
COVID-19
|
0.00%
0/954 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.63%
6/954 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/554 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.4%
4/170 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
41/954 • Number of events 44 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
6.5%
62/954 • Number of events 69 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.2%
23/554 • Number of events 27 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.1%
7/170 • Number of events 8 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.7%
16/954 • Number of events 17 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.9%
28/954 • Number of events 30 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.4%
8/554 • Number of events 10 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.5%
6/170 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
12/954 • Number of events 17 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.2%
21/954 • Number of events 26 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Alanine aminotransferase increased
|
0.63%
6/954 • Number of events 8 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.4%
13/954 • Number of events 16 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.5%
6/170 • Number of events 9 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
12/954 • Number of events 16 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.4%
23/954 • Number of events 29 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.18%
1/554 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.5%
6/170 • Number of events 10 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Blood creatinine increased
|
2.4%
23/954 • Number of events 32 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.9%
37/954 • Number of events 51 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.5%
14/554 • Number of events 19 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Weight decreased
|
4.2%
40/954 • Number of events 42 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
6.8%
65/954 • Number of events 72 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.5%
14/554 • Number of events 17 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.7%
8/170 • Number of events 8 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Investigations
Weight increased
|
1.5%
14/954 • Number of events 15 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.6%
25/954 • Number of events 27 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.3%
7/554 • Number of events 8 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
16/954 • Number of events 24 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.3%
22/954 • Number of events 32 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.6%
9/554 • Number of events 10 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
10/954 • Number of events 10 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.3%
12/954 • Number of events 13 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.36%
2/554 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.4%
4/170 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.1%
30/954 • Number of events 34 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.2%
40/954 • Number of events 49 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.9%
16/554 • Number of events 18 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
106/954 • Number of events 146 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
14.2%
135/954 • Number of events 190 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
10.5%
58/554 • Number of events 69 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
10.0%
17/170 • Number of events 19 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.6%
92/954 • Number of events 104 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
12.4%
118/954 • Number of events 142 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
9.4%
52/554 • Number of events 59 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
5.3%
9/170 • Number of events 9 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
19/954 • Number of events 20 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.1%
20/954 • Number of events 21 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.72%
4/554 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.00%
0/170 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
18/954 • Number of events 21 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.5%
24/954 • Number of events 28 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.3%
7/554 • Number of events 8 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
16/954 • Number of events 20 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.7%
26/954 • Number of events 33 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.54%
3/554 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
60/954 • Number of events 79 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
7.4%
71/954 • Number of events 105 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.4%
19/554 • Number of events 25 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.9%
5/170 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Dizziness
|
4.1%
39/954 • Number of events 47 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
5.0%
48/954 • Number of events 64 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.5%
14/554 • Number of events 17 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Nervous system disorders
Headache
|
4.3%
41/954 • Number of events 59 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
5.6%
53/954 • Number of events 75 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.5%
14/554 • Number of events 15 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.4%
4/170 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Psychiatric disorders
Depression
|
2.1%
20/954 • Number of events 20 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.6%
25/954 • Number of events 27 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.6%
9/554 • Number of events 10 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Psychiatric disorders
Insomnia
|
2.7%
26/954 • Number of events 28 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.7%
35/954 • Number of events 38 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.0%
11/554 • Number of events 11 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.7%
8/170 • Number of events 8 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Dysuria
|
2.5%
24/954 • Number of events 27 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.4%
32/954 • Number of events 37 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.9%
27/554 • Number of events 30 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.9%
5/170 • Number of events 5 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Haematuria
|
3.9%
37/954 • Number of events 48 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
6.9%
66/954 • Number of events 96 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.9%
27/554 • Number of events 39 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
7.1%
12/170 • Number of events 13 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.5%
14/954 • Number of events 17 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.2%
21/954 • Number of events 25 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.72%
4/554 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Nocturia
|
1.8%
17/954 • Number of events 17 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.4%
23/954 • Number of events 24 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
10/554 • Number of events 10 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Pollakiuria
|
4.3%
41/954 • Number of events 46 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
5.3%
51/954 • Number of events 63 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.2%
18/554 • Number of events 20 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.4%
4/170 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Urinary incontinence
|
1.6%
15/954 • Number of events 15 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.5%
24/954 • Number of events 25 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.5%
14/554 • Number of events 14 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Renal and urinary disorders
Urinary retention
|
2.6%
25/954 • Number of events 27 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.1%
39/954 • Number of events 47 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.3%
24/554 • Number of events 29 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Reproductive system and breast disorders
Gynaecomastia
|
2.2%
21/954 • Number of events 21 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.1%
30/954 • Number of events 30 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.1%
6/554 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.4%
13/954 • Number of events 15 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.7%
16/954 • Number of events 19 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.2%
12/554 • Number of events 13 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.59%
1/170 • Number of events 1 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
29/954 • Number of events 34 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.5%
33/954 • Number of events 38 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.0%
11/554 • Number of events 11 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.5%
6/170 • Number of events 6 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
26/954 • Number of events 28 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.4%
32/954 • Number of events 34 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.9%
16/554 • Number of events 22 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
17/954 • Number of events 20 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.3%
22/954 • Number of events 25 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.2%
12/554 • Number of events 14 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
17/954 • Number of events 17 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
2.5%
24/954 • Number of events 27 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
0.72%
4/554 • Number of events 4 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.2%
2/170 • Number of events 2 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Hypertension
|
6.9%
66/954 • Number of events 86 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
9.1%
87/954 • Number of events 117 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
5.6%
31/554 • Number of events 39 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
3.5%
6/170 • Number of events 7 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
|
Vascular disorders
Hot flush
|
5.7%
54/954 • Number of events 58 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
7.0%
67/954 • Number of events 73 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
4.5%
25/554 • Number of events 25 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
1.8%
3/170 • Number of events 3 • From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER