Trial Outcomes & Findings for A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (NCT NCT01492361)
NCT ID: NCT01492361
Last Updated: 2022-04-14
Results Overview
The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
8179 participants
Primary outcome timeframe
Total follow-up time of up to approximately 6 years.
Results posted on
2022-04-14
Participant Flow
Participant milestones
| Measure |
AMR101
AMR101: Parallel Assignment
|
Placebo
Placebo: Parallel Assignment
|
|---|---|---|
|
Overall Study
STARTED
|
4089
|
4090
|
|
Overall Study
Completed Final Visit
|
3419
|
3335
|
|
Overall Study
Death Before Final Visit
|
265
|
295
|
|
Overall Study
COMPLETED
|
3684
|
3630
|
|
Overall Study
NOT COMPLETED
|
405
|
460
|
Reasons for withdrawal
| Measure |
AMR101
AMR101: Parallel Assignment
|
Placebo
Placebo: Parallel Assignment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
281
|
297
|
|
Overall Study
Physician Decision
|
12
|
12
|
|
Overall Study
Lost to Follow-up
|
6
|
13
|
|
Overall Study
Other than specified above
|
106
|
138
|
Baseline Characteristics
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
Baseline characteristics by cohort
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
Total
n=8179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
n=5 Participants
|
64.0 years
n=7 Participants
|
64.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1162 Participants
n=5 Participants
|
1195 Participants
n=7 Participants
|
2357 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2927 Participants
n=5 Participants
|
2895 Participants
n=7 Participants
|
5822 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
3691 Participants
n=5 Participants
|
3688 Participants
n=7 Participants
|
7379 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other than white
|
398 Participants
n=5 Participants
|
401 Participants
n=7 Participants
|
799 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
73 participants
n=5 Participants
|
61 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
123 participants
n=5 Participants
|
127 participants
n=7 Participants
|
250 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
847 participants
n=5 Participants
|
831 participants
n=7 Participants
|
1678 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
109 participants
n=5 Participants
|
93 participants
n=7 Participants
|
202 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1548 participants
n=5 Participants
|
1598 participants
n=7 Participants
|
3146 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
397 participants
n=5 Participants
|
439 participants
n=7 Participants
|
836 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
195 participants
n=5 Participants
|
164 participants
n=7 Participants
|
359 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
213 participants
n=5 Participants
|
201 participants
n=7 Participants
|
414 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
102 participants
n=5 Participants
|
87 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
Region of Enrollment
India
|
130 participants
n=5 Participants
|
132 participants
n=7 Participants
|
262 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
352 participants
n=5 Participants
|
357 participants
n=7 Participants
|
709 participants
n=5 Participants
|
|
Cardiovascular Risk Stratum
Secondary-prevention cohort
|
2892 Participants
n=5 Participants
|
2893 Participants
n=7 Participants
|
5785 Participants
n=5 Participants
|
|
Cardiovascular Risk Stratum
Primary-prevention cohort
|
1197 Participants
n=5 Participants
|
1197 Participants
n=7 Participants
|
2394 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Total follow-up time of up to approximately 6 years.The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
Outcome measures
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
|---|---|---|
|
Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
|
705 Participants
|
901 Participants
|
SECONDARY outcome
Timeframe: Total follow-up time of up to approximately 6 years.The key secondary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.
Outcome measures
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
|---|---|---|
|
Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
|
459 Participants
|
606 Participants
|
SECONDARY outcome
Timeframe: Total follow-up time of up to approximately 6 years.Number of patients with a first occurrence of any component of the composite of CV death or nonfatal MI (including silent MI) during the follow-up period.
Outcome measures
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
|---|---|---|
|
Composite of CV Death or Nonfatal MI (Including Silent MI).
|
392 Participants
|
507 Participants
|
SECONDARY outcome
Timeframe: Total follow-up time of up to approximately 6 years.Number of patients with a first occurrence of fatal or nonfatal MI (including silent MI) during the follow-up period.
Outcome measures
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
|---|---|---|
|
Fatal or Nonfatal MI (Including Silent MI).
|
250 Participants
|
355 Participants
|
SECONDARY outcome
Timeframe: Total follow-up time of up to approximately 6 years.Number of patients with a first occurrence of non-elective coronary revascularization represented as the composite of emergent or urgent classifications during the follow-up period.
Outcome measures
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
|---|---|---|
|
Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.
|
216 Participants
|
321 Participants
|
SECONDARY outcome
Timeframe: Total follow-up time of up to approximately 6 years.Number of patients with an occurrence of CV death during the follow-up period.
Outcome measures
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
|---|---|---|
|
CV Death.
|
174 Participants
|
213 Participants
|
SECONDARY outcome
Timeframe: Total follow-up time of up to approximately 6 years.Number of patients with a first occurrence of unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
Outcome measures
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
|---|---|---|
|
Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
|
108 Participants
|
157 Participants
|
SECONDARY outcome
Timeframe: Total follow-up time of up to approximately 6 years.Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period.
Outcome measures
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
|---|---|---|
|
Fatal or Nonfatal Stroke.
|
98 Participants
|
134 Participants
|
SECONDARY outcome
Timeframe: Total follow-up time of up to approximately 6 years.Number of patients with a first occurrence of any component of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.
Outcome measures
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
|---|---|---|
|
Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
|
549 Participants
|
690 Participants
|
SECONDARY outcome
Timeframe: Total follow-up time of up to approximately 6 years.Number of patients with an occurrence of death from any cause during the follow-up period.
Outcome measures
| Measure |
AMR101
n=4089 Participants
AMR101: Parallel Assignment
|
Placebo
n=4090 Participants
Placebo: Parallel Assignment
|
|---|---|---|
|
Total Mortality.
|
274 Participants
|
310 Participants
|
Adverse Events
AMR101
Serious events: 1252 serious events
Other events: 3268 other events
Deaths: 274 deaths
Placebo
Serious events: 1254 serious events
Other events: 3248 other events
Deaths: 310 deaths
Serious adverse events
| Measure |
AMR101
n=4089 participants at risk
AMR101: Parallel Assignment
|
Placebo
n=4090 participants at risk
Placebo: Parallel Assignment
|
|---|---|---|
|
Infections and infestations
Streptococcal sepsis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Bronchiolitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Bronchitis bacterial
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia
|
2.6%
105/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
2.9%
118/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Cellulitis
|
0.88%
36/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.68%
28/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Sepsis
|
0.61%
25/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.76%
31/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.61%
25/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.54%
22/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.39%
16/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.39%
16/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Erysipelas
|
0.32%
13/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.29%
12/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.17%
7/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Septic shock
|
0.29%
12/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Bronchitis
|
0.27%
11/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.24%
10/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Diverticulitis
|
0.27%
11/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.22%
9/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Urosepsis
|
0.27%
11/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.22%
9/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Appendicitis
|
0.22%
9/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.20%
8/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.17%
7/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Arthritis bacterial
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Wound infection
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Bacteraemia
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Cystitis
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Localised infection
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Arthritis infective
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Abscess limb
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Gangrene
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Intervertebral discitis
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Laryngitis
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Influenza
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Anal abscess
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Herpes zoster
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Liver abscess
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Meningitis bacterial
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Necrotising fasciitis
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Perirectal abscess
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Endocarditis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Viral infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Abscess intestinal
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Implant site infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Peritonitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Bronchitis viral
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia influenzal
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Postoperative abscess
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Catheter site cellulitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Cellulitis streptococcal
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Cystitis bacterial
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Cystitis escherichia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Dengue fever
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Device related sepsis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Diabetic foot infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Diarrhoea infectious
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Epiglottitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Genital infection fungal
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Graft infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Groin abscess
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Hepatitis C
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Incision site abscess
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Infected skin ulcer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Infectious colitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Joint abscess
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Keratitis bacterial
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Latent tuberculosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Mastitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Meningitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Mycobacterial infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Parotitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Peritonitis bacterial
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pharyngolaryngeal abscess
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pilonidal cyst
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Post procedural infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Rectal abscess
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Shunt infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Skin infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Subacute endocarditis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Systemic candida
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Tick-borne fever
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Viral sepsis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Vulval cellulitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Wound sepsis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Orchitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Biliary abscess
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Gas gangrene
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Listeriosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Pyelocystitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.64%
26/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.64%
26/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.34%
14/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.20%
8/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.24%
10/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.20%
8/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.34%
14/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.20%
8/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.22%
9/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.20%
8/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.22%
9/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.17%
7/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucinous adenocarcinoma of appendix
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer male
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix neoplasm
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Iris melanoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer metastatic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant glioma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to chest wall
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to kidney
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal neoplasm
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian granulosa-theca cell tumour
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoid cystic carcinoma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage III
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system neoplasm
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Duodenal neoplasm
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage II
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant mesenteric neoplasm
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucoepidermoid carcinoma of salivary gland
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage III
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer metastatic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile cancer
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory anaemia with ringed sideroblasts
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory cytopenia with unilineage dysplasia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal cancer
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of pharynx
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue cancer metastatic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma recurrent
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral cancer
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Angina pectoris
|
1.2%
48/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
1.2%
48/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Angina unstable
|
1.0%
41/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
1.3%
53/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
21/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.42%
17/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.46%
19/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.32%
13/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.24%
10/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.17%
7/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.22%
9/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.39%
16/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.17%
7/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.20%
8/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.29%
12/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.22%
9/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Palpitations
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Pericarditis
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Left ventricular failure
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Bradycardia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Bundle branch block left
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardiac valve disease
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Pleuropericarditis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Ventricular parasystole
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.64%
26/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.49%
20/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.39%
16/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.29%
12/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.27%
11/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.20%
8/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.24%
10/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.17%
7/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.17%
7/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.20%
8/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.17%
7/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Anal fistula
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.24%
10/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Peritoneal disorder
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Appendix disorder
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Volvulus
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Duodenitis haemorrhagic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
81/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
1.8%
73/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.42%
17/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.27%
11/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.39%
16/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.17%
7/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.27%
11/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.24%
10/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.29%
12/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.24%
10/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.24%
10/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.17%
7/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.22%
9/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Mandibular mass
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic fever
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.81%
33/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.83%
34/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.46%
19/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.44%
18/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.39%
16/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.37%
15/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.39%
16/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.32%
13/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.34%
14/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.54%
22/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
9/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.17%
7/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.27%
11/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
7/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.17%
7/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.17%
7/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mass
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mass
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.39%
16/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.37%
15/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.22%
9/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.20%
8/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.20%
8/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.24%
10/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
End stage renal disease
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Bone fragmentation
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Dislocation of sternum
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural pulmonary embolism
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Axillary nerve injury
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Oesophageal injury
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Poisoning deliberate
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Sciatic nerve injury
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Traumatic renal injury
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Ureteric anastomosis complication
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Chest pain
|
1.6%
66/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
1.6%
66/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Non-cardiac chest pain
|
1.2%
49/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
1.3%
52/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Asthenia
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.20%
8/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Malaise
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Pyrexia
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Oedema peripheral
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
General physical health deterioration
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.17%
7/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Chest discomfort
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Fatigue
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Cyst
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Impaired healing
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Adverse drug reaction
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Chills
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Complication associated with device
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Drowning
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Gait disturbance
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Generalised oedema
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Peripheral swelling
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Swelling
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Ulcer
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Ulcer haemorrhage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Vascular stent restenosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Polyp
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Death
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Pain
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Pelvic mass
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Suprapubic pain
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
47/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.83%
34/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.32%
13/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.29%
12/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.27%
11/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.20%
8/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.17%
7/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal cyst
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Brain injury
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Nephropathy
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Bladder stenosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Incontinence
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal artery fibromuscular dysplasia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal disorder
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal injury
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Ureteric dilatation
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Stag horn calculus
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Syncope
|
0.68%
28/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.76%
31/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
0.27%
11/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.24%
10/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.20%
8/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.17%
7/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Presyncope
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Headache
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Seizure
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Ataxia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Dementia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Epilepsy
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Neuralgia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Aphasia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Hydrocephalus
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Transient global amnesia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Dural arteriovenous fistula
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Intracranial mass
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Migraine
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Nerve compression
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Neurological symptom
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Pseudoradicular syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Quadriplegia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Radicular syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Sensory ganglionitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Speech disorder
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Acute disseminated encephalomyelitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Spinal cord herniation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.39%
16/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.27%
11/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.37%
15/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.34%
14/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.27%
11/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.20%
8/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.24%
10/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.20%
8/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
0.22%
9/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.15%
6/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.37%
15/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.27%
11/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
0.29%
12/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.39%
16/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Hypotension
|
0.22%
9/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.27%
11/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.20%
8/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Aortic stenosis
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.24%
10/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Aortic aneurysm
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Hypovolaemic shock
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Accelerated hypertension
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Haematoma
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Hypertensive emergency
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Intermittent claudication
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Shock
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Angiodysplasia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Arteriovenous fistula
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Circulatory collapse
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Embolism arterial
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Extravasation blood
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Iliac artery occlusion
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Malignant hypertension
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Peripheral embolism
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Renovascular hypertension
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Vena cava thrombosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.37%
15/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.44%
18/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
15/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.17%
7/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.22%
9/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.17%
7/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cryptogenic cirrhosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.54%
22/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.49%
20/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Lymphoid tissue hyperplasia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.44%
18/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.27%
11/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.15%
6/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Prostatism
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Endometrial hypoplasia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Seminal vesicular cyst
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Delirium
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Depression
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Anxiety
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Panic attack
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Alcohol abuse
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Confusional state
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Aggression
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Agitated depression
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Delirium tremens
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Major depression
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Mania
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Lung lobectomy
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Artificial urinary sphincter implant
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Hospitalisation
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Polypectomy
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Shoulder operation
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Stem cell transplant
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Spinal operation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Endotracheal intubation
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Surgical and medical procedures
Transurethral bladder resection
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Troponin increased
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Arteriogram coronary
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Ejection fraction decreased
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Blood pressure increased
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Blood glucose increased
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Weight decreased
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Biopsy pleura
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Prostatic specific antigen increased
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Transaminases increased
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.07%
3/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Blood pressure difference of extremities
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Cardiac murmur
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Ejection fraction abnormal
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Influenza virus test positive
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Cataract
|
0.10%
4/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Retinal detachment
|
0.07%
3/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Eyelid ptosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Retinal haemorrhage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Diplopia
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Eye swelling
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Retinal vein thrombosis
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Chalazion
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.12%
5/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.20%
8/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.12%
5/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Product Issues
Device malfunction
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Product Issues
Device breakage
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Product Issues
Device dislocation
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Product Issues
Device failure
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Product Issues
Device occlusion
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Endocrine disorders
Thyroid mass
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Endocrine disorders
Goitre
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.10%
4/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Immune system disorders
Anaphylactic shock
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.05%
2/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.02%
1/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.05%
2/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Congenital, familial and genetic disorders
Pancreas divisum
|
0.02%
1/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
0.00%
0/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
Other adverse events
| Measure |
AMR101
n=4089 participants at risk
AMR101: Parallel Assignment
|
Placebo
n=4090 participants at risk
Placebo: Parallel Assignment
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.4%
178/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
5.5%
224/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Eye disorders
Cataract
|
5.6%
230/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
5.0%
205/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.9%
363/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
11.0%
450/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
216/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
3.5%
142/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Oedema peripheral
|
6.5%
264/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
4.9%
201/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Fatigue
|
5.6%
227/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
4.8%
195/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
General disorders
Chest pain
|
5.5%
226/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
5.9%
240/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
314/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
7.3%
300/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.6%
311/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
7.7%
315/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Bronchitis
|
7.2%
295/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
7.1%
292/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Influenza
|
6.4%
261/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
6.5%
267/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
240/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
6.0%
246/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
322/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
7.4%
303/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
309/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
7.5%
306/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
232/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
5.8%
239/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
5.6%
227/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
5.8%
238/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
243/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
5.7%
233/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
241/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
5.9%
241/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
7.6%
312/4089 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
8.1%
333/4090 • Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment.
Adverse events were collected from first dose of study treatment until the completion or withdrawal from study plus 30 days post treatment.
|
Additional Information
Dr. Alexander Giaquinto, Executive Director, Regulatory Affairs
Amarin Pharma, Inc.
Phone: 908-326-1324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place