Trial Outcomes & Findings for A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation (NCT NCT00174785)
NCT ID: NCT00174785
Last Updated: 2010-01-12
Results Overview
The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4628 participants
Primary outcome timeframe
minimum follow-up duration: 1 year ; maximum: 2.5 years
Results posted on
2010-01-12
Participant Flow
Enrollment of patients started on June 29, 2005 and was completed on December 30, 2006. The study was conducted at 551 centers in 37 countries. The common study end date ensuring a minimum planned follow-up of one year was December 30th, 2007.
Participant milestones
| Measure |
Dronedarone 400mg Bid
dronedarone tablets 400mg twice daily
|
Placebo
matching placebo tablets
|
|---|---|---|
|
Overall Study
STARTED
|
2301
|
2327
|
|
Overall Study
COMPLETED
|
1605
|
1611
|
|
Overall Study
NOT COMPLETED
|
696
|
716
|
Reasons for withdrawal
| Measure |
Dronedarone 400mg Bid
dronedarone tablets 400mg twice daily
|
Placebo
matching placebo tablets
|
|---|---|---|
|
Overall Study
Adverse Event
|
293
|
191
|
|
Overall Study
Protocol Violation
|
14
|
14
|
|
Overall Study
Withdrawal by Subject
|
173
|
175
|
|
Overall Study
Atrial Fibrillation/Flutter recurrence
|
110
|
167
|
|
Overall Study
Prohibited antiarrhythmic medication
|
39
|
88
|
|
Overall Study
Other prohibited medication
|
5
|
3
|
|
Overall Study
Family request
|
6
|
8
|
|
Overall Study
Not pre-specified/Not coded
|
56
|
70
|
Baseline Characteristics
A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Dronedarone 400mg Bid
n=2301 Participants
dronedarone tablets 400mg twice daily
|
Placebo
n=2327 Participants
matching placebo tablets
|
Total
n=4628 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to < 65 years
|
431 participants
n=5 Participants
|
442 participants
n=7 Participants
|
873 participants
n=5 Participants
|
|
Age, Customized
65 to < 75 years
|
923 participants
n=5 Participants
|
907 participants
n=7 Participants
|
1830 participants
n=5 Participants
|
|
Age, Customized
>= 75 years
|
947 participants
n=5 Participants
|
978 participants
n=7 Participants
|
1925 participants
n=5 Participants
|
|
Age Continuous
|
71.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
71.7 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
71.6 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1131 Participants
n=5 Participants
|
1038 Participants
n=7 Participants
|
2169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1170 Participants
n=5 Participants
|
1289 Participants
n=7 Participants
|
2459 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: minimum follow-up duration: 1 year ; maximum: 2.5 yearsPopulation: All efficacy analyses were performed on the "all randomized patients" population including all patients randomized irrespective of whether the patient actually received any drug or complied with the study protocol.
The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Outcome measures
| Measure |
Dronedarone 400mg Bid
n=2301 Participants
dronedarone tablets 400mg twice daily
|
Placebo
n=2327 Participants
matching placebo tablets
|
|---|---|---|
|
First Hospitalization for Cardiovascular Reason or Death From Any Cause
|
734 participants
|
917 participants
|
SECONDARY outcome
Timeframe: minimum follow-up duration: 1 year ; maximum: 2.5 yearsPopulation: "All randomized patients" population
The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Outcome measures
| Measure |
Dronedarone 400mg Bid
n=2301 Participants
dronedarone tablets 400mg twice daily
|
Placebo
n=2327 Participants
matching placebo tablets
|
|---|---|---|
|
Death From Any Cause
|
116 participants
|
139 participants
|
SECONDARY outcome
Timeframe: minimum follow-up duration: 1 year ; maximum: 2.5 yearsPopulation: "All randomized patients" population
The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Outcome measures
| Measure |
Dronedarone 400mg Bid
n=2301 Participants
dronedarone tablets 400mg twice daily
|
Placebo
n=2327 Participants
matching placebo tablets
|
|---|---|---|
|
First Hospitalization for Cardiovascular Reason
|
675 participants
|
859 participants
|
SECONDARY outcome
Timeframe: minimum follow-up duration: 1 year ; maximum: 2.5 yearsPopulation: "All randomized patients" population
The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Outcome measures
| Measure |
Dronedarone 400mg Bid
n=2301 Participants
dronedarone tablets 400mg twice daily
|
Placebo
n=2327 Participants
matching placebo tablets
|
|---|---|---|
|
Cardiovascular Death
|
65 participants
|
94 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: minimum follow-up duration: 1 year ; maximum: 2.5 yearsPopulation: "All randomized patients" population
The considered event is cardiovascular death, as assessed by the blinded adjudication of the Steering Committee. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Outcome measures
| Measure |
Dronedarone 400mg Bid
n=2301 Participants
dronedarone tablets 400mg twice daily
|
Placebo
n=2327 Participants
matching placebo tablets
|
|---|---|---|
|
Adjudicated Cardiovascular Death
|
63 participants
|
90 participants
|
Adverse Events
Dronedarone 400mg Bid
Serious events: 456 serious events
Other events: 1584 other events
Deaths: 0 deaths
Placebo
Serious events: 489 serious events
Other events: 1527 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dronedarone 400mg Bid
n=2291 participants at risk
dronedarone tablets 400mg twice daily
|
Placebo
n=2313 participants at risk
matching placebo tablets
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.57%
13/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.82%
19/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
5/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Surgical and medical procedures
Ileostomy closure
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pneumonia
|
1.4%
32/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
1.9%
45/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Urinary tract infection
|
0.26%
6/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.43%
10/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Cellulitis
|
0.22%
5/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.30%
7/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Gastroenteritis
|
0.22%
5/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.26%
6/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Lobar pneumonia
|
0.22%
5/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.26%
6/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Diverticulitis
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Bronchitis
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Appendicitis
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Bronchopneumonia
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Sepsis
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Urosepsis
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Herpes zoster
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pyelonephritis
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Bronchiectasis
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Mastitis
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Septic shock
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Viral infection
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Abscess
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Abscess limb
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Abscess oral
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Acarodermatitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Clonorchiasis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Diarrhoea infectious
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Encephalitis viral
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Epstein-barr virus infection
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Escherichia sepsis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Gastroenteritis viral
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Hepatitis a
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Infected epidermal cyst
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Infection
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Influenza
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Localised infection
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Opisthorchiasis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Orchitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Osteomyelitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pancreatitis viral
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Peritoneal infection
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pneumonia bacterial
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Rectal abscess
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Respiratory tract infection
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Skin infection
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Soft tissue infection
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Wound infection bacterial
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Obstructive chronic bronchitis with acute exacerbation
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Groin infection
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Hiv infection
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Paronychia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Peridiverticular abscess
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Pyothorax
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.26%
6/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.22%
5/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
6/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Gastritis
|
0.22%
5/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Nausea
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Constipation
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Ileus
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Colitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Anal prolapse
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Food poisoning
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Oesophageal mass
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Peritonitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Toothache
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Hiatus hernia, obstructive
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Mesenteric occlusion
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Short-bowel syndrome
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.26%
6/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.48%
11/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.22%
5/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.22%
5/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.22%
5/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma metastatic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma malignant
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral adenoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign peritoneal neoplasm
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage iii
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory carcinoma of the breast
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular neoplasm
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary serous endometrial carcinoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleura carcinoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Fall
|
0.87%
20/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.86%
20/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.22%
5/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Device failure
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Medical device pain
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Postoperative heterotopic calcification
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.22%
5/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Device migration
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Penetrating abdominal trauma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Traumatic arthropathy
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
15/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.91%
21/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.22%
5/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis acquired
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Renal failure acute
|
0.61%
14/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Haematuria
|
0.31%
7/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.30%
7/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Calculus urinary
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Urinary retention
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Renal colic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Renal failure
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Calculus bladder
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Nocturia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Renal impairment
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.26%
6/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.22%
5/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
6/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Cholangitis
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.30%
7/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Biliary colic
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Jaundice
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.43%
10/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Gout
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Dizziness
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Ischaemic stroke
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Sciatica
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Syncope
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Brain mass
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Headache
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Pseudobulbar palsy
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Spinal claudication
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Diplegia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Mononeuritis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Blood creatinine increased
|
0.22%
5/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
International normalised ratio increased
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.26%
6/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Weight decreased
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Cardioactive drug level increased
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Coagulation test abnormal
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
International normalised ratio decreased
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Prothrombin time prolonged
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Hepatitis c positive
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Transaminases increased
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Bradycardia
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Cardiac failure
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Pericardial effusion
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Angina pectoris
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Cardiac tamponade
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Coronary artery disease
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Sinus bradycardia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Torsade de pointes
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Ventricle rupture
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Aortic valve calcification
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Ventricular flutter
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.35%
8/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.43%
10/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Penis disorder
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Non-cardiac chest pain
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Asthenia
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Pyrexia
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
General physical health deterioration
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Drowning
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Oedema
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Oedema peripheral
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Multi-organ failure
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Hernia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Impaired healing
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Implant site haematoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Injection site haematoma
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.30%
7/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Cataract
|
0.17%
4/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Glaucoma
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Open angle glaucoma
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Retinal detachment
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Maculopathy
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Ulcerative keratitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Blindness
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Myopia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Ocular retrobulbar haemorrhage
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Pterygium
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Eye disorders
Uveitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Haematoma
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Aortic aneurysm
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Haemorrhage
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Hypovolaemic shock
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Angiodysplasia
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Iliac artery embolism
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Depression
|
0.13%
3/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Mental status changes
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Major depression
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Endocrine disorders
Hyperthyroidism
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Endocrine disorders
Goitre
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Endocrine disorders
Hypothyroidism
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.09%
2/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Endocrine disorders
Adrenal disorder
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Surgical and medical procedures
Suprapubic catheter insertion
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.13%
3/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Surgical and medical procedures
Pilonidal sinus repair
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Ear and labyrinth disorders
Vertigo
|
0.09%
2/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.17%
4/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Immune system disorders
Hypersensitivity
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Social circumstances
Victim of crime
|
0.04%
1/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.00%
0/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
0.04%
1/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
Other adverse events
| Measure |
Dronedarone 400mg Bid
n=2291 participants at risk
dronedarone tablets 400mg twice daily
|
Placebo
n=2313 participants at risk
matching placebo tablets
|
|---|---|---|
|
Gastrointestinal disorders
Any Gastrointestinal disorders
|
25.0%
573/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
20.7%
478/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
222/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
6.1%
142/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
122/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
3.1%
71/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Infections and infestations
Any infections and infestations
|
22.2%
508/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
23.0%
533/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Any general disorders and administration site conditions
|
17.3%
397/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
15.0%
348/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Oedema peripheral
|
6.4%
147/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
5.1%
119/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
General disorders
Fatigue
|
5.0%
115/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
3.9%
90/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Any musculoskeletal and connective tissue disorders
|
15.9%
364/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
16.3%
376/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Any nervous system disorders
|
15.8%
362/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
15.8%
365/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Nervous system disorders
Dizziness
|
7.0%
160/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
6.3%
145/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Any respiratory, thoracic and mediastinal disorders
|
13.7%
315/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
13.7%
318/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.2%
120/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
4.2%
96/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Investigations
Any investigation disorders
|
13.0%
298/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
8.6%
199/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Cardiac disorders
Any cardiac disorders
|
11.0%
251/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
9.2%
213/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Skin and subcutaneous tissue disorders
Any skin and subcutaneous tissue disorders
|
10.3%
235/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
7.5%
174/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Injury, poisoning and procedural complications
Any injury, poisoning and procedural complications
|
8.2%
187/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
8.6%
198/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Vascular disorders
Any vascular disorders
|
7.8%
179/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
8.1%
187/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Metabolism and nutrition disorders
Any metabolism and nutrition disorders
|
7.5%
171/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
7.9%
183/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
|
Psychiatric disorders
Any psychiatric disorders
|
4.6%
106/2291 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
5.4%
125/2313 • In both treatment groups, the median duration of exposure was about 18 months, with a maximum of 30 months.
Reported Events are Treatment-Emergent Adverse Events with an onset date between the first study drug intake and the last study drug intake + 10 days and any pre-treatment adverse event that led to study drug permanent discontinuation.
|
Additional Information
International Clinical Development (ICD), Clinical Study Director
sanofi-aventis
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such publication for comment at least 45 days before any submission for publication. If requested by the Sponsor, any submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER