Trial Outcomes & Findings for Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (NCT NCT02548351)
NCT ID: NCT02548351
Last Updated: 2024-10-01
Results Overview
All potential liver-related clinical outcomes that occurred after administration of first dose of investigational product were reviewed and adjudicated by blinded, independent Hepatic Outcomes Committee(HOC). Adjudicated results were used to assess effect of OCA, compared to placebo in conjunction with established local standard of care, on clinical outcomes in participants with NASH as measured by time to first occurrence of any of following adjudicated events, derived as a composite event endpoint of death(all-cause), liver transplant, Model of End-stage Liver Disease(MELD)≥15 Score, hospitalization(defined by a stay of 24 hours or greater) for onset of: variceal bleed, hepatic encephalopathy(defined by a West Haven score of ≥2), and spontaneous bacterial peritonitis(confirmed by diagnostic paracentesis), ascites secondary to cirrhosis requiring medical intervention, and histological progression to Cirrhosis. Clinical events distribution was estimated using Kaplan-Meier methodology.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
2477 participants
Primary outcome timeframe
Up to 7 years
Results posted on
2024-10-01
Participant Flow
This was a phase 3, double-blind, randomized, long-term, placebo-controlled, multicenter study evaluating the safety and efficacy of Obeticholic Acid (OCA) in Participants with Nonalcoholic Steatohepatitis (NASH).
The study was conducted at approximately 350 investigational sites globally.
Participant milestones
| Measure |
OCA 10 Milligrams (mg)
Participants were randomized to receive OCA 10 mg once daily orally with water.
|
OCA 25 mg
Participants were randomized to receive OCA 25 mg once daily orally with water.
|
Placebo
Participants were randomized to receive matching placebo once daily orally with water.
|
|---|---|---|---|
|
Overall Study
STARTED
|
825
|
827
|
825
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
825
|
827
|
825
|
Reasons for withdrawal
| Measure |
OCA 10 Milligrams (mg)
Participants were randomized to receive OCA 10 mg once daily orally with water.
|
OCA 25 mg
Participants were randomized to receive OCA 25 mg once daily orally with water.
|
Placebo
Participants were randomized to receive matching placebo once daily orally with water.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
149
|
154
|
152
|
|
Overall Study
Death
|
11
|
15
|
12
|
|
Overall Study
Adverse Event
|
22
|
56
|
36
|
|
Overall Study
Study Terminated by Sponsor
|
549
|
509
|
528
|
|
Overall Study
Site Closure
|
14
|
5
|
7
|
|
Overall Study
Non-compliance with Study Drug
|
4
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
2
|
|
Overall Study
Physician Decision
|
11
|
18
|
11
|
|
Overall Study
Lost to Follow-up
|
43
|
50
|
57
|
|
Overall Study
Other
|
19
|
16
|
20
|
|
Overall Study
Missing
|
1
|
1
|
0
|
Baseline Characteristics
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
Baseline characteristics by cohort
| Measure |
OCA 10 Milligrams (mg)
n=825 Participants
Participants were randomized to receive OCA 10 mg once daily orally with water.
|
OCA 25 mg
n=827 Participants
Participants were randomized to receive OCA 25 mg once daily orally with water.
|
Placebo
n=825 Participants
Participants were randomized to receive matching placebo once daily orally with water.
|
Total
n=2477 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.3 Years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
55.3 Years
STANDARD_DEVIATION 11.71 • n=7 Participants
|
54.4 Years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
55.3 Years
STANDARD_DEVIATION 11.24 • n=4 Participants
|
|
Sex: Female, Male
Female
|
475 Participants
n=5 Participants
|
494 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
1447 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
350 Participants
n=5 Participants
|
333 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
1030 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
129 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
425 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
620 Participants
n=5 Participants
|
594 Participants
n=7 Participants
|
592 Participants
n=5 Participants
|
1806 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
76 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
246 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
679 Participants
n=5 Participants
|
674 Participants
n=7 Participants
|
685 Participants
n=5 Participants
|
2038 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
72 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPopulation: Intent-to-Treat (ITT) Population comprised of all randomized participants with fibrosis stage 2 or stage 3 who receive at least 1 dose of investigational product.
All potential liver-related clinical outcomes that occurred after administration of first dose of investigational product were reviewed and adjudicated by blinded, independent Hepatic Outcomes Committee(HOC). Adjudicated results were used to assess effect of OCA, compared to placebo in conjunction with established local standard of care, on clinical outcomes in participants with NASH as measured by time to first occurrence of any of following adjudicated events, derived as a composite event endpoint of death(all-cause), liver transplant, Model of End-stage Liver Disease(MELD)≥15 Score, hospitalization(defined by a stay of 24 hours or greater) for onset of: variceal bleed, hepatic encephalopathy(defined by a West Haven score of ≥2), and spontaneous bacterial peritonitis(confirmed by diagnostic paracentesis), ascites secondary to cirrhosis requiring medical intervention, and histological progression to Cirrhosis. Clinical events distribution was estimated using Kaplan-Meier methodology.
Outcome measures
| Measure |
OCA 10 Milligrams (mg)
n=729 Participants
Participants were randomized to receive OCA 10 mg once daily orally with water.
|
OCA 25 mg
n=730 Participants
Participants were randomized to receive OCA 25 mg once daily orally with water.
|
Placebo
n=728 Participants
Participants were randomized to receive matching placebo once daily orally with water.
|
|---|---|---|---|
|
Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event
|
15.8 Percentage of participants
Interval 13.2 to 18.6
|
14.7 Percentage of participants
Interval 12.2 to 17.4
|
18.8 Percentage of participants
Interval 16.0 to 21.9
|
SECONDARY outcome
Timeframe: Up to 7 yearsPopulation: ITT Population.
Fibrosis stage was evaluated by NASH Clinical Research Network (CRN) Fibrosis Staging System as follows: Stage 0: No fibrosis, Stage 1: Perisinusoidal/periportal fibrosis, Stage 1A: Mild, zone 3, perisinusoidal fibrosis, Stage 1B: Moderate, zone 3, perisinusoidal fibrosis, Stage 1C: Portal/periportal fibrosis, Stage 2: Perisinusoidal and portal/periportal fibrosis, Stage 3: Bridging fibrosis and Stage 4: Cirrhosis. No worsening of NASH was defined as no worsening of hepatocellular ballooning, no worsening of lobular inflammation, and no worsening of steatosis. Responders are defined as participants who did not discontinue treatment due to Adverse event (AE) or did not die and had evaluable post-Baseline biopsy assessment. Mantel-Haenszel method is used to construct the confidence intervals.
Outcome measures
| Measure |
OCA 10 Milligrams (mg)
n=729 Participants
Participants were randomized to receive OCA 10 mg once daily orally with water.
|
OCA 25 mg
n=730 Participants
Participants were randomized to receive OCA 25 mg once daily orally with water.
|
Placebo
n=728 Participants
Participants were randomized to receive matching placebo once daily orally with water.
|
|---|---|---|---|
|
Percentage of Responders With Improvement of Fibrosis by at Least One Stage With no Worsening of NASH Using Consensus Read Method of Scheduled Liver Biopsies
|
17.1 Percentage of participants
|
19.5 Percentage of participants
|
10.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 7 yearsPopulation: ITT Population.
Fibrosis stage was evaluated by NASH Clinical Research Network(CRN) Fibrosis Staging System as follows: Stage 0:No fibrosis, Stage 1:Perisinusoidal/periportal fibrosis, Stage 1A:Mild, zone 3, perisinusoidal fibrosis, Stage 1B:Moderate, zone3, perisinusoidal fibrosis, Stage 1C:Portal/periportal fibrosis, Stage 2:Perisinusoidal and portal/periportal fibrosis, Stage 3:Bridging fibrosis and Stage 4:Cirrhosis. Resolution of NASH (Nonalcoholic Steatohepatitis) is defined as absence of fatty liver disease, or presence of simple or isolated steatosis without steatohepatitis, with a NAS(NAFLD Activity Score) of 0 for ballooning and 0 to 1 for inflammation. NAS ranges from 0-12; 0: no features of fatty liver disease and 12: highest degree of fatty liver disease. Higher signify worse symptoms. Responders are who did not discontinue treatment due to Adverse event(AE) or did not die and had evaluable post-Baseline biopsy assessment. Mantel-Haenszel method is used to construct confidence intervals.
Outcome measures
| Measure |
OCA 10 Milligrams (mg)
n=729 Participants
Participants were randomized to receive OCA 10 mg once daily orally with water.
|
OCA 25 mg
n=730 Participants
Participants were randomized to receive OCA 25 mg once daily orally with water.
|
Placebo
n=728 Participants
Participants were randomized to receive matching placebo once daily orally with water.
|
|---|---|---|---|
|
Percentage of Participants Who Showed Improvement in Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either Using Consensus Read Method
|
18.5 Percentage of participants
|
20.8 Percentage of participants
|
11.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 7 yearsPopulation: Safety Population comprised all randomized participants, all fibrosis stages, who receive at least 1 dose of investigational product (OCA or placebo).
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as any AE that either newly appeared, increased in frequency, or worsened in severity following treatment up to 30 days from last dose of permanent investigational product discontinuation. Serious AE (SAE) was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event.
Outcome measures
| Measure |
OCA 10 Milligrams (mg)
n=825 Participants
Participants were randomized to receive OCA 10 mg once daily orally with water.
|
OCA 25 mg
n=827 Participants
Participants were randomized to receive OCA 25 mg once daily orally with water.
|
Placebo
n=825 Participants
Participants were randomized to receive matching placebo once daily orally with water.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
798 Participants
|
813 Participants
|
781 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
273 Participants
|
276 Participants
|
248 Participants
|
Adverse Events
OCA 10 Milligrams (mg)
Serious events: 273 serious events
Other events: 798 other events
Deaths: 14 deaths
OCA 25 mg
Serious events: 276 serious events
Other events: 813 other events
Deaths: 19 deaths
Placebo
Serious events: 248 serious events
Other events: 781 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
OCA 10 Milligrams (mg)
n=825 participants at risk
Participants were randomized to receive OCA 10 mg once daily orally with water.
|
OCA 25 mg
n=827 participants at risk
Participants were randomized to receive OCA 25 mg once daily orally with water.
|
Placebo
n=825 participants at risk
Participants were randomized to receive matching placebo once daily orally with water.
|
|---|---|---|---|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.85%
7/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.73%
6/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.85%
7/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.85%
7/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.73%
6/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Angina unstable
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.97%
8/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.60%
5/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardio-respiratory distress
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cor pulmonale
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.85%
7/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Pericarditis constrictive
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Congenital, familial and genetic disorders
Congenital cerebrovascular anomaly
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Congenital, familial and genetic disorders
Rathke's cleft cyst
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Labyrinthine fistula
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Adrenal haematoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Goitre
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Pituitary-dependent Cushing's syndrome
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.85%
7/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.85%
7/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal wall disorder
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Apical granuloma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Appendix disorder
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyschezia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.73%
6/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.60%
5/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Breast complication associated with device
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Calcinosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Chest pain
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.97%
8/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.73%
6/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Death
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Device deployment issue
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Device dislocation
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Disease progression
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Dysplasia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Impaired healing
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Mass
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.85%
7/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Vascular stent occlusion
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Biloma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
1.1%
9/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.97%
8/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholestatic liver injury
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Abscess limb
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Anal infection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Arthritis bacterial
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.60%
5/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.73%
6/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Chronic sinusitis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Coccidioidomycosis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Corona virus infection
|
0.73%
6/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.85%
7/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.73%
6/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cytomegalovirus mononucleosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Diarrhoea infectious
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Encephalitis viral
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Endocarditis bacterial
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Escherichia sepsis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gangrene
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Graft infection
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Hepatitis E
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Histoplasmosis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Infection
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Joint abscess
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Liver abscess
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Localised infection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Medical device site joint infection
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Parotid abscess
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Peritonitis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pharyngeal abscess
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
1.1%
9/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.85%
7/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia viral
|
1.1%
9/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
1.2%
10/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Post procedural sepsis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pulmonary sepsis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis syndrome
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tonsillitis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tooth infection
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.60%
5/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urosepsis
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Varicella
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Vestibular neuronitis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Vulval abscess
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication pulmonary
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Pharyngeal injury
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.73%
6/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Skin graft failure
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Arthroscopy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Coronavirus test positive
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Fibrin D dimer increased
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Transaminases increased
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Troponin increased
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Weight increased
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Inclusion body myositis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.73%
6/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.73%
6/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.97%
8/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.73%
6/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendon calcification
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of salivary gland
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatic neoplasm
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of spinal cord
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangiopericytoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.97%
8/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.73%
6/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic adenoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyosarcoma
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Ataxia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Brain mass
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dementia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysarthria
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Lacunar stroke
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Migraine
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Motor neurone disease
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Nerve compression
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Optic neuritis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Parkinson's disease
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Parkinsonism
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Spinal epidural haemorrhage
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.85%
7/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Thalamic infarction
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Transient global amnesia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Bipolar disorder
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Psychogenic seizure
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Psychogenic tremor
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Rapid eye movements sleep abnormal
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.73%
6/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
1.6%
13/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.48%
4/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.60%
5/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal aneurysm
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic congestion
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Rectocele
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.60%
5/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.61%
5/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.60%
5/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngeal polyp
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.36%
3/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilum mass
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.60%
5/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Liver transplant
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Physiotherapy
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
ANXIETY-DEPRESSIVE DISORDER
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
INTRACRANIAL HEMORRHAGE
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PNEUMONIA METASTASIS OF OESOPHAGEAL CANCER
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Arterial occlusive disease
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Arteriosclerosis
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertensive emergency
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.24%
2/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.36%
3/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Shock
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.24%
2/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.12%
1/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
0.00%
0/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
OCA 10 Milligrams (mg)
n=825 participants at risk
Participants were randomized to receive OCA 10 mg once daily orally with water.
|
OCA 25 mg
n=827 participants at risk
Participants were randomized to receive OCA 25 mg once daily orally with water.
|
Placebo
n=825 participants at risk
Participants were randomized to receive matching placebo once daily orally with water.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
35.6%
294/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
56.8%
470/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
25.5%
210/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
46/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
7.4%
61/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.8%
48/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.8%
15/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
6.7%
55/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
1.6%
13/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
17.8%
147/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
18.3%
151/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
16.1%
133/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
88/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
12.5%
103/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
10.2%
84/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
9.9%
82/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
9.7%
80/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
8.5%
70/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
9.0%
74/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
8.8%
73/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
9.7%
80/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
9.8%
81/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
8.0%
66/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
8.0%
66/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
7.4%
61/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
7.6%
63/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
7.2%
59/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
17.9%
148/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
20.0%
165/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
18.2%
150/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.8%
139/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
16.3%
135/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
16.0%
132/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
13.9%
115/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
15.5%
128/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
11.2%
92/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.5%
95/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
12.6%
104/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
12.8%
106/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
112/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
13.1%
108/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
17.6%
145/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
71/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
10.9%
90/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
8.0%
66/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
51/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
7.6%
63/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.7%
47/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.2%
59/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
6.9%
57/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.8%
48/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
48/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
4.2%
35/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.0%
41/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Low-density lipoprotein increased
|
21.2%
175/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
22.1%
183/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
11.2%
92/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Blood cholesterol increased
|
6.4%
53/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
6.2%
51/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
3.9%
32/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
6.4%
53/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.2%
43/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.2%
43/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Glycosylated haemoglobin increased
|
5.7%
47/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
4.8%
40/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
4.5%
37/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
4.6%
38/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
3.3%
27/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.6%
46/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
37/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
3.1%
26/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.9%
49/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.4%
28/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
1.7%
14/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.2%
43/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.2%
117/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
16.0%
132/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
16.2%
134/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.5%
136/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
12.7%
105/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
14.5%
120/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.1%
67/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
8.1%
67/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
8.0%
66/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
47/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.9%
49/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
7.3%
60/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.9%
65/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
6.4%
53/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
7.4%
61/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
13.6%
112/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
12.0%
99/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
11.4%
94/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
9.7%
80/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
10.9%
90/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
4.0%
33/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.9%
57/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.8%
48/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
3.2%
26/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
8.5%
70/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.7%
47/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
7.3%
60/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
17.9%
148/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
16.3%
135/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
16.7%
138/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
5.7%
47/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
4.7%
39/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.1%
42/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
10.1%
83/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
10.5%
87/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
10.9%
90/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
7.5%
62/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
6.4%
53/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
6.7%
55/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.0%
58/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
6.0%
50/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.3%
44/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
44/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
3.6%
30/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
4.8%
40/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.8%
81/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
8.3%
69/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
7.5%
62/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
8.2%
68/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
6.7%
55/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.8%
48/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
7.6%
63/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
6.5%
54/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
7.5%
62/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
5.5%
45/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
6.5%
54/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
5.1%
42/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
6.1%
50/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
8.0%
66/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
3.6%
30/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
12.8%
106/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
11.7%
97/827 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
10.7%
88/825 • Up to 7 years
Treatment emergent adverse events and serious adverse events were collected in the Safety Population. Safety Population comprises of participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place