Trial Outcomes & Findings for Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men (NCT NCT02716675)
NCT ID: NCT02716675
Last Updated: 2022-02-23
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
2699 participants
Primary outcome timeframe
Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.
Results posted on
2022-02-23
Participant Flow
Participants were randomly assigned to the placebo, low-dose VRC01, or high-dose VRC01 arm. The pooled VRC01 arm represents participants assigned to low-dose or high-dose VRC01 and is the primary comparison group for the primary analysis of prevention efficacy.
Participant milestones
| Measure |
Placebo
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|
|
Overall Study
STARTED
|
903
|
899
|
897
|
|
Overall Study
Modified Intent-to-treat Population
|
898
|
895
|
894
|
|
Overall Study
COMPLETED
|
703
|
702
|
686
|
|
Overall Study
NOT COMPLETED
|
200
|
197
|
211
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
3
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
100
|
87
|
99
|
|
Overall Study
Withdrawal by Subject
|
22
|
25
|
20
|
|
Overall Study
Protocol Violation
|
0
|
3
|
1
|
|
Overall Study
Participant Unable to Adhere to Visit Schedule
|
36
|
31
|
42
|
|
Overall Study
Other
|
38
|
47
|
48
|
Baseline Characteristics
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men
Baseline characteristics by cohort
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Total
n=2699 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28 years
n=93 Participants
|
28 years
n=4 Participants
|
27 years
n=27 Participants
|
28 years
n=483 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Customized
18 - 20 years
|
95 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
295 Participants
n=483 Participants
|
|
Age, Customized
21 - 30 years
|
496 Participants
n=93 Participants
|
474 Participants
n=4 Participants
|
480 Participants
n=27 Participants
|
1450 Participants
n=483 Participants
|
|
Age, Customized
31 - 40 years
|
232 Participants
n=93 Participants
|
253 Participants
n=4 Participants
|
208 Participants
n=27 Participants
|
693 Participants
n=483 Participants
|
|
Age, Customized
41 - 50 years
|
80 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
260 Participants
n=483 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
892 Participants
n=93 Participants
|
892 Participants
n=4 Participants
|
889 Participants
n=27 Participants
|
2673 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
532 Participants
n=93 Participants
|
517 Participants
n=4 Participants
|
495 Participants
n=27 Participants
|
1544 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
371 Participants
n=93 Participants
|
382 Participants
n=4 Participants
|
402 Participants
n=27 Participants
|
1155 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
69 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
132 Participants
n=93 Participants
|
132 Participants
n=4 Participants
|
144 Participants
n=27 Participants
|
408 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
286 Participants
n=93 Participants
|
272 Participants
n=4 Participants
|
293 Participants
n=27 Participants
|
851 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
32 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
88 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
421 Participants
n=93 Participants
|
425 Participants
n=4 Participants
|
413 Participants
n=27 Participants
|
1259 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
460 Participants
n=93 Participants
|
464 Participants
n=4 Participants
|
457 Participants
n=27 Participants
|
1381 Participants
n=483 Participants
|
|
Region of Enrollment
Brazil
|
51 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
151 Participants
n=483 Participants
|
|
Region of Enrollment
Peru
|
380 Participants
n=93 Participants
|
374 Participants
n=4 Participants
|
377 Participants
n=27 Participants
|
1131 Participants
n=483 Participants
|
|
Region of Enrollment
Switzerland
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · None
|
812 Participants
|
794 Participants
|
805 Participants
|
1599 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Mild
|
90 Participants
|
104 Participants
|
88 Participants
|
192 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Moderate
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · None
|
754 Participants
|
741 Participants
|
759 Participants
|
1500 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Mild
|
145 Participants
|
153 Participants
|
133 Participants
|
286 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Moderate
|
4 Participants
|
5 Participants
|
5 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · None
|
718 Participants
|
702 Participants
|
720 Participants
|
1422 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Mild
|
180 Participants
|
191 Participants
|
170 Participants
|
361 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Moderate
|
5 Participants
|
6 Participants
|
7 Participants
|
13 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: >= 10cm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None
|
877 Participants
|
878 Participants
|
882 Participants
|
1760 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 1: 2.5 to less than 5cm
|
17 Participants
|
13 Participants
|
13 Participants
|
26 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 2: 5 to less than 10cm
|
9 Participants
|
8 Participants
|
2 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 3: >= 10cm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 4: complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · None
|
896 Participants
|
894 Participants
|
894 Participants
|
1788 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 1: 2.5 to less than 5cm
|
7 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 2: 5 to less than 10cm
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 3: >= 10cm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 4: complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
874 Participants
|
876 Participants
|
880 Participants
|
1756 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 1: 2.5 to less than 5cm
|
20 Participants
|
15 Participants
|
14 Participants
|
29 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 2: 5 to less than 10cm
|
9 Participants
|
8 Participants
|
3 Participants
|
11 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 4: complications AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
74 Participants
|
74 Participants
|
77 Participants
|
151 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
664 Participants
|
672 Participants
|
691 Participants
|
1363 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
197 Participants
|
182 Participants
|
169 Participants
|
351 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
39 Participants
|
45 Participants
|
36 Participants
|
81 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
809 Participants
|
802 Participants
|
820 Participants
|
1622 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
81 Participants
|
76 Participants
|
61 Participants
|
137 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
13 Participants
|
21 Participants
|
15 Participants
|
36 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
728 Participants
|
714 Participants
|
731 Participants
|
1445 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
146 Participants
|
147 Participants
|
137 Participants
|
284 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
28 Participants
|
35 Participants
|
29 Participants
|
64 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
821 Participants
|
814 Participants
|
812 Participants
|
1626 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
8 Participants
|
10 Participants
|
8 Participants
|
18 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · None
|
889 Participants
|
873 Participants
|
881 Participants
|
1754 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Mild
|
12 Participants
|
24 Participants
|
12 Participants
|
36 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
|
2 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
857 Participants
|
843 Participants
|
861 Participants
|
1704 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
41 Participants
|
45 Participants
|
29 Participants
|
74 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
5 Participants
|
11 Participants
|
6 Participants
|
17 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
861 Participants
|
848 Participants
|
869 Participants
|
1717 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
39 Participants
|
44 Participants
|
21 Participants
|
65 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
3 Participants
|
7 Participants
|
7 Participants
|
14 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
556 Participants
|
546 Participants
|
563 Participants
|
1109 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
286 Participants
|
277 Participants
|
273 Participants
|
550 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
57 Participants
|
72 Participants
|
59 Participants
|
131 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
4 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased Body Temperature · None
|
880 Participants
|
879 Participants
|
870 Participants
|
1749 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased Body Temperature · Mild
|
14 Participants
|
11 Participants
|
14 Participants
|
25 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased Body Temperature · Moderate
|
7 Participants
|
7 Participants
|
12 Participants
|
19 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased Body Temperature · Severe
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased Body Temperature · Potentially Life-threatening
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 0
|
25 U/L
Interval 17.0 to 35.0
|
24 U/L
Interval 17.0 to 36.0
|
24 U/L
Interval 17.0 to 35.0
|
24 U/L
Interval 17.0 to 35.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 8
|
24 U/L
Interval 17.0 to 35.0
|
24 U/L
Interval 16.0 to 36.0
|
24 U/L
Interval 17.0 to 33.0
|
24 U/L
Interval 17.0 to 35.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 16
|
23 U/L
Interval 17.0 to 35.0
|
23 U/L
Interval 17.0 to 34.0
|
24 U/L
Interval 17.0 to 34.0
|
23 U/L
Interval 17.0 to 34.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 24
|
24 U/L
Interval 17.0 to 35.0
|
23 U/L
Interval 17.0 to 33.0
|
23 U/L
Interval 16.0 to 33.0
|
23 U/L
Interval 16.0 to 33.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 32
|
24 U/L
Interval 17.0 to 34.0
|
23 U/L
Interval 17.0 to 34.0
|
23 U/L
Interval 16.0 to 33.0
|
23 U/L
Interval 16.0 to 33.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 40
|
23 U/L
Interval 16.0 to 33.0
|
22 U/L
Interval 16.0 to 33.0
|
22 U/L
Interval 16.0 to 33.0
|
22 U/L
Interval 16.0 to 33.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 48
|
23 U/L
Interval 16.0 to 33.0
|
23 U/L
Interval 16.0 to 33.0
|
22 U/L
Interval 15.0 to 31.0
|
22 U/L
Interval 16.0 to 32.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 56
|
22 U/L
Interval 16.0 to 34.0
|
22 U/L
Interval 16.0 to 33.0
|
22 U/L
Interval 16.0 to 30.0
|
22 U/L
Interval 16.0 to 32.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 64
|
22 U/L
Interval 16.0 to 33.0
|
22 U/L
Interval 16.0 to 33.0
|
22 U/L
Interval 15.0 to 31.0
|
22 U/L
Interval 16.0 to 32.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 72
|
22 U/L
Interval 16.0 to 32.0
|
22 U/L
Interval 16.0 to 31.0
|
22 U/L
Interval 16.0 to 31.0
|
22 U/L
Interval 16.0 to 31.0
|
PRIMARY outcome
Timeframe: Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 0
|
0.86 mg/dL
Interval 0.76 to 0.98
|
0.86 mg/dL
Interval 0.75 to 0.97
|
0.86 mg/dL
Interval 0.76 to 0.99
|
0.86 mg/dL
Interval 0.75 to 0.98
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 8
|
0.87 mg/dL
Interval 0.77 to 0.98
|
0.86 mg/dL
Interval 0.76 to 0.97
|
0.88 mg/dL
Interval 0.77 to 0.99
|
0.87 mg/dL
Interval 0.77 to 0.98
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 16
|
0.88 mg/dL
Interval 0.78 to 0.99
|
0.87 mg/dL
Interval 0.77 to 0.98
|
0.87 mg/dL
Interval 0.78 to 0.99
|
0.87 mg/dL
Interval 0.77 to 0.99
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 24
|
0.87 mg/dL
Interval 0.77 to 0.99
|
0.88 mg/dL
Interval 0.78 to 0.99
|
0.88 mg/dL
Interval 0.77 to 1.0
|
0.88 mg/dL
Interval 0.77 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 32
|
0.88 mg/dL
Interval 0.77 to 0.99
|
0.87 mg/dL
Interval 0.78 to 0.99
|
0.87 mg/dL
Interval 0.77 to 1.0
|
0.87 mg/dL
Interval 0.78 to 0.99
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 40
|
0.88 mg/dL
Interval 0.78 to 0.99
|
0.88 mg/dL
Interval 0.78 to 1.0
|
0.88 mg/dL
Interval 0.78 to 1.0
|
0.88 mg/dL
Interval 0.78 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 48
|
0.88 mg/dL
Interval 0.78 to 1.0
|
0.89 mg/dL
Interval 0.79 to 0.99
|
0.89 mg/dL
Interval 0.78 to 1.01
|
0.89 mg/dL
Interval 0.79 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 56
|
0.88 mg/dL
Interval 0.78 to 0.99
|
0.89 mg/dL
Interval 0.78 to 1.0
|
0.88 mg/dL
Interval 0.8 to 1.0
|
0.88 mg/dL
Interval 0.79 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 64
|
0.88 mg/dL
Interval 0.78 to 1.0
|
0.89 mg/dL
Interval 0.8 to 1.0
|
0.89 mg/dL
Interval 0.79 to 1.0
|
0.89 mg/dL
Interval 0.79 to 1.0
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 72
|
0.89 mg/dL
Interval 0.79 to 0.99
|
0.88 mg/dL
Interval 0.8 to 1.0
|
0.89 mg/dL
Interval 0.8 to 1.01
|
0.89 mg/dL
Interval 0.8 to 1.0
|
PRIMARY outcome
Timeframe: Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 0
|
14.9 g/dL
Interval 14.1 to 15.6
|
14.8 g/dL
Interval 14.2 to 15.6
|
14.9 g/dL
Interval 14.1 to 15.6
|
14.8 g/dL
Interval 14.2 to 15.6
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 8
|
14.7 g/dL
Interval 14.1 to 15.5
|
14.7 g/dL
Interval 13.9 to 15.4
|
14.8 g/dL
Interval 14.1 to 15.5
|
14.7 g/dL
Interval 14.0 to 15.4
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 16
|
14.7 g/dL
Interval 14.0 to 15.5
|
14.7 g/dL
Interval 14.0 to 15.4
|
14.7 g/dL
Interval 14.0 to 15.4
|
14.7 g/dL
Interval 14.0 to 15.4
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 24
|
14.6 g/dL
Interval 14.0 to 15.4
|
14.6 g/dL
Interval 13.9 to 15.3
|
14.7 g/dL
Interval 14.0 to 15.3
|
14.7 g/dL
Interval 14.0 to 15.3
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 32
|
14.6 g/dL
Interval 14.0 to 15.3
|
14.6 g/dL
Interval 13.9 to 15.3
|
14.7 g/dL
Interval 13.9 to 15.3
|
14.6 g/dL
Interval 13.9 to 15.3
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 40
|
14.6 g/dL
Interval 13.9 to 15.5
|
14.5 g/dL
Interval 13.8 to 15.3
|
14.6 g/dL
Interval 13.9 to 15.4
|
14.6 g/dL
Interval 13.8 to 15.3
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 48
|
14.6 g/dL
Interval 13.9 to 15.4
|
14.6 g/dL
Interval 13.8 to 15.3
|
14.6 g/dL
Interval 13.8 to 15.3
|
14.6 g/dL
Interval 13.8 to 15.3
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 56
|
14.6 g/dL
Interval 13.9 to 15.4
|
14.6 g/dL
Interval 13.7 to 15.3
|
14.6 g/dL
Interval 13.9 to 15.3
|
14.6 g/dL
Interval 13.8 to 15.3
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 64
|
14.6 g/dL
Interval 13.8 to 15.3
|
14.5 g/dL
Interval 13.7 to 15.4
|
14.6 g/dL
Interval 13.8 to 15.3
|
14.5 g/dL
Interval 13.8 to 15.3
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 72
|
14.5 g/dL
Interval 13.9 to 15.3
|
14.5 g/dL
Interval 13.7 to 15.2
|
14.5 g/dL
Interval 13.8 to 15.3
|
14.5 g/dL
Interval 13.7 to 15.3
|
PRIMARY outcome
Timeframe: Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 0
|
1988.5 cells/cubic mm
Interval 1620.0 to 2363.0
|
1980 cells/cubic mm
Interval 1600.0 to 2406.0
|
1971 cells/cubic mm
Interval 1645.0 to 2370.0
|
1978.5 cells/cubic mm
Interval 1620.0 to 2392.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 8
|
1926 cells/cubic mm
Interval 1610.0 to 2296.0
|
1904 cells/cubic mm
Interval 1571.0 to 2264.0
|
1947.5 cells/cubic mm
Interval 1596.0 to 2310.0
|
1930 cells/cubic mm
Interval 1590.0 to 2294.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 16
|
1927.5 cells/cubic mm
Interval 1600.0 to 2289.0
|
1896 cells/cubic mm
Interval 1593.5 to 2325.5
|
1915.5 cells/cubic mm
Interval 1592.0 to 2349.5
|
1900.5 cells/cubic mm
Interval 1593.0 to 2339.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 24
|
1950 cells/cubic mm
Interval 1600.0 to 2295.0
|
1925 cells/cubic mm
Interval 1580.0 to 2320.0
|
1911 cells/cubic mm
Interval 1600.0 to 2336.0
|
1920 cells/cubic mm
Interval 1596.0 to 2330.5
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 32
|
1957 cells/cubic mm
Interval 1610.0 to 2300.0
|
1930 cells/cubic mm
Interval 1560.0 to 2300.0
|
1900 cells/cubic mm
Interval 1580.0 to 2309.5
|
1920 cells/cubic mm
Interval 1570.0 to 2304.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 40
|
1890 cells/cubic mm
Interval 1560.0 to 2294.0
|
1900 cells/cubic mm
Interval 1525.0 to 2295.0
|
1879 cells/cubic mm
Interval 1570.0 to 2250.0
|
1890 cells/cubic mm
Interval 1550.0 to 2263.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 48
|
1923.5 cells/cubic mm
Interval 1600.0 to 2271.0
|
1923 cells/cubic mm
Interval 1570.0 to 2320.0
|
1870 cells/cubic mm
Interval 1570.0 to 2260.0
|
1900 cells/cubic mm
Interval 1570.0 to 2290.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 56
|
1910 cells/cubic mm
Interval 1582.0 to 2290.0
|
1887.5 cells/cubic mm
Interval 1565.0 to 2310.0
|
1900.5 cells/cubic mm
Interval 1600.0 to 2294.0
|
1895.5 cells/cubic mm
Interval 1582.5 to 2300.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 64
|
1922 cells/cubic mm
Interval 1593.0 to 2300.0
|
1890 cells/cubic mm
Interval 1580.0 to 2311.0
|
1870 cells/cubic mm
Interval 1570.0 to 2260.0
|
1880 cells/cubic mm
Interval 1580.0 to 2300.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 72
|
1940 cells/cubic mm
Interval 1590.0 to 2236.0
|
1930 cells/cubic mm
Interval 1542.0 to 2267.0
|
1900 cells/cubic mm
Interval 1560.0 to 2280.0
|
1910 cells/cubic mm
Interval 1556.0 to 2270.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 0
|
3586 cells/cubic mm
Interval 2754.0 to 4495.0
|
3593 cells/cubic mm
Interval 2720.0 to 4514.0
|
3534 cells/cubic mm
Interval 2705.0 to 4505.0
|
3571.5 cells/cubic mm
Interval 2715.0 to 4510.5
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 8
|
3410 cells/cubic mm
Interval 2727.0 to 4236.0
|
3460 cells/cubic mm
Interval 2650.0 to 4540.0
|
3424 cells/cubic mm
Interval 2798.0 to 4460.0
|
3437 cells/cubic mm
Interval 2708.0 to 4502.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 16
|
3378 cells/cubic mm
Interval 2578.0 to 4355.0
|
3377 cells/cubic mm
Interval 2549.5 to 4246.0
|
3360 cells/cubic mm
Interval 2600.0 to 4305.0
|
3361.5 cells/cubic mm
Interval 2580.0 to 4283.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 24
|
3330 cells/cubic mm
Interval 2610.0 to 4212.0
|
3417 cells/cubic mm
Interval 2554.0 to 4430.0
|
3306 cells/cubic mm
Interval 2538.0 to 4350.0
|
3357.5 cells/cubic mm
Interval 2550.0 to 4400.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 32
|
3344 cells/cubic mm
Interval 2543.0 to 4300.0
|
3360 cells/cubic mm
Interval 2501.0 to 4380.0
|
3336 cells/cubic mm
Interval 2582.5 to 4289.0
|
3350 cells/cubic mm
Interval 2550.0 to 4352.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 40
|
3310 cells/cubic mm
Interval 2560.0 to 4195.0
|
3260 cells/cubic mm
Interval 2500.0 to 4400.0
|
3300 cells/cubic mm
Interval 2516.0 to 4200.0
|
3287 cells/cubic mm
Interval 2500.0 to 4320.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 48
|
3322 cells/cubic mm
Interval 2675.0 to 4344.5
|
3284.5 cells/cubic mm
Interval 2560.0 to 4240.0
|
3266.5 cells/cubic mm
Interval 2583.0 to 4205.0
|
3278 cells/cubic mm
Interval 2580.0 to 4224.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 56
|
3340 cells/cubic mm
Interval 2612.0 to 4320.0
|
3238.5 cells/cubic mm
Interval 2500.0 to 4290.0
|
3200 cells/cubic mm
Interval 2519.0 to 4100.0
|
3212.5 cells/cubic mm
Interval 2508.0 to 4192.5
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 64
|
3245 cells/cubic mm
Interval 2560.0 to 4180.0
|
3240 cells/cubic mm
Interval 2495.0 to 4275.0
|
3228 cells/cubic mm
Interval 2576.0 to 4100.0
|
3230 cells/cubic mm
Interval 2520.0 to 4190.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 72
|
3286.5 cells/cubic mm
Interval 2530.0 to 4123.0
|
3245 cells/cubic mm
Interval 2420.0 to 4180.0
|
3304 cells/cubic mm
Interval 2550.0 to 4298.0
|
3272 cells/cubic mm
Interval 2500.0 to 4259.0
|
PRIMARY outcome
Timeframe: Measured at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72.Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics are presented by treatment group and timepoint.
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 56
|
254 1000 cells/cubic mm
Interval 220.0 to 294.0
|
256 1000 cells/cubic mm
Interval 219.0 to 296.0
|
251 1000 cells/cubic mm
Interval 215.0 to 292.0
|
253 1000 cells/cubic mm
Interval 217.0 to 294.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 16
|
249.5 1000 cells/cubic mm
Interval 216.0 to 287.0
|
252 1000 cells/cubic mm
Interval 214.0 to 293.0
|
251 1000 cells/cubic mm
Interval 214.0 to 291.0
|
251 1000 cells/cubic mm
Interval 214.0 to 292.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 24
|
251.5 1000 cells/cubic mm
Interval 217.0 to 290.95
|
250 1000 cells/cubic mm
Interval 215.0 to 292.0
|
251 1000 cells/cubic mm
Interval 214.0 to 287.0
|
250.5 1000 cells/cubic mm
Interval 214.0 to 289.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 40
|
250.7 1000 cells/cubic mm
Interval 218.0 to 289.0
|
254.5 1000 cells/cubic mm
Interval 215.3 to 294.0
|
250 1000 cells/cubic mm
Interval 213.0 to 288.0
|
252 1000 cells/cubic mm
Interval 214.0 to 291.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 48
|
251 1000 cells/cubic mm
Interval 220.0 to 290.0
|
256 1000 cells/cubic mm
Interval 219.0 to 291.0
|
251 1000 cells/cubic mm
Interval 215.0 to 289.0
|
253 1000 cells/cubic mm
Interval 217.0 to 290.2
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 64
|
254 1000 cells/cubic mm
Interval 219.0 to 291.0
|
256 1000 cells/cubic mm
Interval 219.0 to 296.0
|
249 1000 cells/cubic mm
Interval 216.0 to 289.0
|
252 1000 cells/cubic mm
Interval 217.0 to 293.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 72
|
254 1000 cells/cubic mm
Interval 221.0 to 297.0
|
253 1000 cells/cubic mm
Interval 220.0 to 298.0
|
253 1000 cells/cubic mm
Interval 219.0 to 289.0
|
253 1000 cells/cubic mm
Interval 219.0 to 293.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 32
|
252 1000 cells/cubic mm
Interval 218.0 to 290.0
|
253.5 1000 cells/cubic mm
Interval 216.0 to 296.0
|
250 1000 cells/cubic mm
Interval 215.0 to 289.0
|
252 1000 cells/cubic mm
Interval 215.75 to 291.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 0
|
6.33 1000 cells/cubic mm
Interval 5.28 to 7.5
|
6.4 1000 cells/cubic mm
Interval 5.28 to 7.66
|
6.3 1000 cells/cubic mm
Interval 5.2 to 7.5
|
6.3 1000 cells/cubic mm
Interval 5.25 to 7.6
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 8
|
6.2 1000 cells/cubic mm
Interval 5.2 to 7.4
|
6.1 1000 cells/cubic mm
Interval 5.01 to 7.41
|
6.2 1000 cells/cubic mm
Interval 5.1 to 7.5
|
6.12 1000 cells/cubic mm
Interval 5.07 to 7.5
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 16
|
6.1 1000 cells/cubic mm
Interval 4.99 to 7.3
|
6.1 1000 cells/cubic mm
Interval 5.0 to 7.3
|
6.1 1000 cells/cubic mm
Interval 5.01 to 7.33
|
6.1 1000 cells/cubic mm
Interval 5.0 to 7.3
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 24
|
6.1 1000 cells/cubic mm
Interval 5.1 to 7.3
|
6.15 1000 cells/cubic mm
Interval 5.03 to 7.43
|
6.05 1000 cells/cubic mm
Interval 5.0 to 7.43
|
6.1 1000 cells/cubic mm
Interval 5.01 to 7.43
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 32
|
6.1 1000 cells/cubic mm
Interval 4.96 to 7.33
|
6.1 1000 cells/cubic mm
Interval 5.0 to 7.4
|
6.05 1000 cells/cubic mm
Interval 5.0 to 7.4
|
6.1 1000 cells/cubic mm
Interval 5.0 to 7.4
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 40
|
6.09 1000 cells/cubic mm
Interval 5.0 to 7.3
|
6.09 1000 cells/cubic mm
Interval 4.9 to 7.3
|
5.95 1000 cells/cubic mm
Interval 5.0 to 7.21
|
6 1000 cells/cubic mm
Interval 4.9 to 7.25
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 48
|
6.16 1000 cells/cubic mm
Interval 5.1 to 7.41
|
6 1000 cells/cubic mm
Interval 5.0 to 7.21
|
6 1000 cells/cubic mm
Interval 5.03 to 7.14
|
6 1000 cells/cubic mm
Interval 5.0 to 7.18
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 56
|
6.1 1000 cells/cubic mm
Interval 5.05 to 7.3
|
6.04 1000 cells/cubic mm
Interval 4.88 to 7.43
|
5.9 1000 cells/cubic mm
Interval 4.94 to 7.12
|
6 1000 cells/cubic mm
Interval 4.9 to 7.3
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 64
|
6.05 1000 cells/cubic mm
Interval 5.04 to 7.2
|
5.9 1000 cells/cubic mm
Interval 4.9 to 7.38
|
5.95 1000 cells/cubic mm
Interval 4.9 to 7.11
|
5.94 1000 cells/cubic mm
Interval 4.9 to 7.2
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 72
|
5.91 1000 cells/cubic mm
Interval 5.0 to 7.1
|
5.92 1000 cells/cubic mm
Interval 4.89 to 7.2
|
6.05 1000 cells/cubic mm
Interval 5.0 to 7.3
|
6 1000 cells/cubic mm
Interval 4.9 to 7.22
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 0
|
248.5 1000 cells/cubic mm
Interval 213.0 to 286.0
|
248 1000 cells/cubic mm
Interval 210.0 to 289.0
|
249 1000 cells/cubic mm
Interval 214.0 to 290.0
|
248.1 1000 cells/cubic mm
Interval 212.0 to 290.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 8
|
248 1000 cells/cubic mm
Interval 214.95 to 289.0
|
250 1000 cells/cubic mm
Interval 213.0 to 291.0
|
248 1000 cells/cubic mm
Interval 213.0 to 288.0
|
249 1000 cells/cubic mm
Interval 213.0 to 290.0
|
PRIMARY outcome
Timeframe: Measured at Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72.Population: Safety population. Participants may not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
The number (percentage) of participants with chemistry and hematology laboratory measures meeting grade 3 AE criteria or above as specified in the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\] is tabulated by treatment group and timepoint. Excludes measures taken prior to exposure to study product at Week 0/Infusion 1.
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 8
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 16
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 24
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 32
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 40
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 48
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 56
|
1 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 64
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 72
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 32
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 64
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 72
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 8
|
7 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 16
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 24
|
6 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Lymphocytes (cells/cubic mm)- Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 32
|
4 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 40
|
5 Participants
|
7 Participants
|
6 Participants
|
13 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 48
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 56
|
5 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 64
|
3 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 72
|
4 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
WBC (1000/cubic mm)- Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
WBC (1000/cubic mm)- Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
WBC (1000/cubic mm)- Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
WBC (1000/cubic mm)- Week 32
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
WBC (1000/cubic mm)- Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
WBC (1000/cubic mm)- Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
WBC (1000/cubic mm)- Week 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
WBC (1000/cubic mm)- Week 64
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
WBC (1000/cubic mm)- Week 72
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Platelets (1000/cubic mm)- Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Platelets (1000/cubic mm)- Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Platelets (1000/cubic mm)- Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Platelets (1000/cubic mm)- Week 32
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Platelets (1000/cubic mm)- Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Platelets (1000/cubic mm)- Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Platelets (1000/cubic mm)- Week 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Platelets (1000/cubic mm)- Week 64
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Platelets (1000/cubic mm)- Week 72
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Lymphocytes (cells/cubic mm)- Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Lymphocytes (cells/cubic mm)- Week 24
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Lymphocytes (cells/cubic mm)- Week 32
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Lymphocytes (cells/cubic mm)- Week 40
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Lymphocytes (cells/cubic mm)- Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Lymphocytes (cells/cubic mm)- Week 56
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Lymphocytes (cells/cubic mm)- Week 64
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Lymphocytes (cells/cubic mm)- Week 72
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Neutrophils (cells/cubic mm)- Week 8
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Neutrophils (cells/cubic mm)- Week 16
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Neutrophils (cells/cubic mm)- Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Neutrophils (cells/cubic mm)- Week 32
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Neutrophils (cells/cubic mm)- Week 40
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Neutrophils (cells/cubic mm)- Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Neutrophils (cells/cubic mm)- Week 56
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Neutrophils (cells/cubic mm)- Week 64
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Neutrophils (cells/cubic mm)- Week 72
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Week 72 (the last infusion visit).Population: Safety population
The number (percentage) of participants with early permanent discontinuation of infusions and their reason for discontinuation is summarized by treatment group. Includes all discontinuations documented on a study case report form.
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Other
|
11 Participants
|
6 Participants
|
7 Participants
|
13 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Pregnancy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
HIV infection
|
37 Participants
|
32 Participants
|
21 Participants
|
53 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Death
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Clinical event other than reactogenicity
|
14 Participants
|
16 Participants
|
20 Participants
|
36 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Reactogenicity Symptom
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Investigator Reason
|
7 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Participant refused study product infusion
|
5 Participants
|
5 Participants
|
7 Participants
|
12 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Co-enrollment in a study
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Two(2) reactive HIV tests
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Termination from study for non-medical reason(s)
|
69 Participants
|
75 Participants
|
80 Participants
|
155 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
No Discontinuation
|
759 Participants
|
759 Participants
|
757 Participants
|
1516 Participants
|
PRIMARY outcome
Timeframe: Measured through Week 72 (the last infusion visit).Population: Safety population
Incidence rate (95% CI) of early infusion discontinuation per 100 person years. Includes discontinuations documented on a study case report form and operational discontinuations defined as 20 consecutive weeks without participant contact. Discontinuations due to pregnancy, death, or HIV-1 infection are right-censored.
Outcome measures
| Measure |
Placebo
n=903 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Incidence Rate of Early Infusion Discontinuation
|
8.9 events per 100 person years
Interval 7.3 to 10.7
|
10 events per 100 person years
Interval 8.3 to 11.9
|
8.8 events per 100 person years
Interval 7.2 to 10.6
|
—
|
PRIMARY outcome
Timeframe: Measured through Week 80.Population: MITT population
Prevention efficacy (PE) is measured as 1 minus the ratio (VRC01:control) of cumulative incidences of HIV-1 infection diagnosis between enrollment and the week 80 visit for assessment of the primary efficacy end point. Cumulative incidence was estimated with the Nelson-Aalen estimator for the cumulative hazard function, with stratification according to VRC01 dose and trial.
Outcome measures
| Measure |
Placebo
n=898 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=895 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=894 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1789 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Number of Participants With Documented HIV-1 Infection by the Week 80 Visit
|
38 Participants
|
32 Participants
|
28 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Day 61 (5 days post infusion #2), Midpoint (4-weeks post infusion visits): Weeks 4, 12, 16, 28, 36, 44, 52, 60, 68, 76 and Trough (infusion visits): Pre dose at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.Population: Pilot study population
The pharmacokinetic analyses of VRC01 involved a subgroup of VRC01 recipients who had not acquired HIV-1 infection through the week 88 visit and were not likely to have used preexposure prophylaxis (on the basis of self-report or testing of dried blood-spot samples), randomly sampled among the trials and dose groups. Midpoint and trough concentrations are the participant-level median concentrations at the 4-week and 8-week postinfusion visits, respectively, across all 10 infusion intervals.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=12 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Serum Concentration of VRC01 in Participants Assigned to Receive the mAb
4-week post infusion visit
|
23.1 μg/ml
Interval 8.8 to 43.9
|
55.1 μg/ml
Interval 26.6 to 89.5
|
—
|
—
|
|
Serum Concentration of VRC01 in Participants Assigned to Receive the mAb
8-week post infusion visit
|
5.8 μg/ml
Interval 1.5 to 18.3
|
15.4 μg/ml
Interval 4.5 to 29.8
|
—
|
—
|
|
Serum Concentration of VRC01 in Participants Assigned to Receive the mAb
Day 61
|
65.7 μg/ml
Interval 41.7 to 116.1
|
212 μg/ml
Interval 125.5 to 287.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured through Week 80.Population: MITT population
The VRC01 80% inhibitory concentration (IC80) of acquired isolates was measured with the TZM-bl assay using the earliest available post-HIV-infection serum sample. Median and IQR are summarized immediately below, then the analysis of prevention efficacy was repeated for each of three prespecified categories of in vitro susceptibility of the infecting strain (IC80 less than 1 μg per milliliter, 1 to 3 μg per milliliter, or \>3 μg per milliliter) with the use of the Aalen-Johansen estimator.
Outcome measures
| Measure |
Placebo
n=898 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=895 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=894 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1789 Participants
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
VRC01 Clinical Lot Neutralization of Founder Viruses (IC80)
|
3.28 μg/ml
Interval 0.79 to 8.58
|
4.7 μg/ml
Interval 2.39 to 19.43
|
5.78 μg/ml
Interval 2.3 to 12.56
|
4.97 μg/ml
Interval 2.34 to 15.86
|
SECONDARY outcome
Timeframe: First RNA+ Sample detected from baseline up to Week 104.Population: Subset of HIV-infected VRC01 recipients
Autologous titer (ID50, ID80) summaries, based on most sensitive virus, for first RNA+ samples from a subset of HIV-infected VRC01 recipients. Values below the limit of detection (less than 10) were set to NA. Summaries are only computed for the Pooled VRC01 arm.
Outcome measures
| Measure |
Placebo
n=31 Participants
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
VRC01 Serum Neutralization of Autologous Founder Viruses (ID50, ID80)
ID50
|
NA titer
Interval to 125.3
Values below the limit of detection (less than 10) were set to NA.
|
—
|
—
|
—
|
|
VRC01 Serum Neutralization of Autologous Founder Viruses (ID50, ID80)
ID80
|
NA titer
Interval to 34.18
Values below the limit of detection (less than 10) were set to NA.
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 32 serious events
Other events: 750 other events
Deaths: 2 deaths
Low-Dose VRC01
Serious events: 35 serious events
Other events: 771 other events
Deaths: 3 deaths
High-Dose VRC01
Serious events: 32 serious events
Other events: 742 other events
Deaths: 0 deaths
Pooled VRC01
Serious events: 67 serious events
Other events: 1513 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Placebo
n=903 participants at risk
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 participants at risk
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 participants at risk
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 participants at risk
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Investigations
Any Event in SOC
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Platelet count decreased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Any Event in SOC
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Any Event in SOC
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Myocardial infarction
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Any Event in SOC
|
0.33%
3/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Enterocolitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Nausea
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Vomiting
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Any Event in SOC
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Non-cardiac chest pain
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Any Event in SOC
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Any Event in SOC
|
1.1%
10/903 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.6%
14/899 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
24/1796 • Number of events 25 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Abscess limb
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Anal abscess
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Appendicitis
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
COVID-19
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Cellulitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Endocarditis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Febrile infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Lung abscess
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pneumonia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Shigella infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Varicella
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
0.55%
5/903 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Any Event in SOC
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Radial nerve palsy
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Syncope
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Any Event in SOC
|
1.1%
10/903 • Number of events 18 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
12/897 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
20/1796 • Number of events 25 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Alcoholism
|
0.22%
2/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Bipolar disorder
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Depression
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Major depression
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Mania
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Psychotic disorder
|
0.22%
2/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Substance dependence
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Suicidal ideation
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Suicide attempt
|
0.44%
4/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Any Event in SOC
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
Other adverse events
| Measure |
Placebo
n=903 participants at risk
Placebo (Sodium Chloride, USP 0.9%) by intravenous (IV) infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Low-Dose VRC01
n=899 participants at risk
VRC01 mAb by intravenous (IV) infusion at a dose of 10 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
High-Dose VRC01
n=897 participants at risk
VRC01 mAb by intravenous (IV) infusion at a dose of 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
Pooled VRC01
n=1796 participants at risk
VRC01 mAb by intravenous (IV) infusion at a dose of 10 or 30 mg/kg at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72.
|
|---|---|---|---|---|
|
Social circumstances
Any Event in SOC
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Social circumstances
Physical assault
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Social circumstances
Victim of sexual abuse
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Genital cyst
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Any Event in SOC
|
1.9%
17/903 • Number of events 18 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.9%
26/899 • Number of events 28 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.6%
23/897 • Number of events 29 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.7%
49/1796 • Number of events 57 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
11/903 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
15/899 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.6%
14/897 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.6%
29/1796 • Number of events 33 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Microcytosis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Any Event in SOC
|
0.78%
7/903 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Brugada syndrome
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Intracardiac mass
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Palpitations
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Sinus tachycardia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Cardiac disorders
Tachycardia
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Congenital, familial and genetic disorders
Any Event in SOC
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Congenital, familial and genetic disorders
Encephalocele
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Congenital, familial and genetic disorders
Frenulum breve
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Congenital, familial and genetic disorders
Tourette's disorder
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Any Event in SOC
|
1.3%
12/903 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.9%
17/899 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
22/1796 • Number of events 24 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Ear pain
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/899 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Vertigo
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Endocrine disorders
Any Event in SOC
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Any Event in SOC
|
1.6%
14/903 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/899 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/897 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
19/1796 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Blepharitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Blepharospasm
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Cataract
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Chalazion
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Diplopia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Dry eye
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Eye inflammation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Eye irritation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Eye pain
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Eye pruritus
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Eye swelling
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Keratitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Keratoconus
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Lagophthalmos
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Macular degeneration
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Ocular hyperaemia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Retinal detachment
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Scintillating scotoma
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Strabismus
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Swelling of eyelid
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Eye disorders
Vision blurred
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Any Event in SOC
|
17.2%
155/903 • Number of events 211 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
20.4%
183/899 • Number of events 269 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
19.5%
175/897 • Number of events 253 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
19.9%
358/1796 • Number of events 522 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.89%
8/903 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/897 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
19/1796 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Anal fissure
|
0.44%
4/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/899 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/897 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
18/1796 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Anal fistula
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Anal pruritus
|
0.89%
8/903 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Anal skin tags
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Anal ulcer
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Colitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Constipation
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Dental caries
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
10/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Diarrhoea
|
6.3%
57/903 • Number of events 64 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
5.5%
49/899 • Number of events 62 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
6.5%
58/897 • Number of events 66 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
6.0%
107/1796 • Number of events 128 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
9/897 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
12/1796 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Enteritis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Flatulence
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Food poisoning
|
1.3%
12/903 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.0%
18/899 • Number of events 18 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
15/897 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.8%
33/1796 • Number of events 34 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gastritis
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.66%
6/903 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.84%
15/1796 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
11/903 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.3%
21/899 • Number of events 23 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
31/1796 • Number of events 33 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Hypertrophy of tongue papillae
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Lip erosion
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Lip ulceration
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Malpositioned teeth
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Mouth cyst
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Nausea
|
1.1%
10/903 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.0%
18/899 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.8%
16/897 • Number of events 18 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.9%
34/1796 • Number of events 37 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Oral pain
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Oral papule
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Proctalgia
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Proctitis
|
0.55%
5/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/897 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
16/1796 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Rectal discharge
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Rectal fissure
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Stomatitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Swollen tongue
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Tooth demineralisation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Tooth impacted
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Toothache
|
0.66%
6/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
18/1796 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Gastrointestinal disorders
Vomiting
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/899 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.61%
11/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Any Event in SOC
|
7.2%
65/903 • Number of events 77 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
9.8%
88/899 • Number of events 106 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
8.9%
80/897 • Number of events 93 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
9.4%
168/1796 • Number of events 199 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Adverse drug reaction
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.61%
11/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Adverse food reaction
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Asthenia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Axillary pain
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Chest discomfort
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Chest pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Chills
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Cyst
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Drug withdrawal syndrome
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Early satiety
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Fatigue
|
1.2%
11/903 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.4%
13/899 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
12/897 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.4%
25/1796 • Number of events 26 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Feeling hot
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Hangover
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Induration
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Influenza like illness
|
4.1%
37/903 • Number of events 38 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.0%
36/899 • Number of events 39 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.0%
36/897 • Number of events 39 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.0%
72/1796 • Number of events 78 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Infusion site bruising
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Infusion site extravasation
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/899 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Infusion site irritation
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Infusion site pruritus
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Injection site bruising
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Injection site pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Injection site pruritus
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Injection site reaction
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Injury associated with device
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Lithiasis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Malaise
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Nodule
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Non-cardiac chest pain
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Oedema peripheral
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Peripheral swelling
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Puncture site pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Pyrexia
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
12/1796 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Swelling
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Temperature intolerance
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Ulcer
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
General disorders
Xerosis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Any Event in SOC
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Deficiency of bile secretion
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Immune system disorders
Any Event in SOC
|
2.5%
23/903 • Number of events 25 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.1%
19/899 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
12/897 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
31/1796 • Number of events 33 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Immune system disorders
Drug hypersensitivity
|
0.44%
4/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Immune system disorders
Food allergy
|
0.44%
4/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Immune system disorders
Hypersensitivity
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Immune system disorders
Jarisch-Herxheimer reaction
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Immune system disorders
Mite allergy
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Immune system disorders
Multiple allergies
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Immune system disorders
Seasonal allergy
|
1.1%
10/903 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
9/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.84%
15/1796 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Any Event in SOC
|
65.4%
591/903 • Number of events 1612 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
68.1%
612/899 • Number of events 1732 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
65.2%
585/897 • Number of events 1669 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
66.6%
1197/1796 • Number of events 3401 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Abscess limb
|
0.66%
6/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.61%
11/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Abscess neck
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Acariasis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Acarodermatitis
|
2.1%
19/903 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.0%
18/899 • Number of events 21 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.9%
17/897 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.9%
35/1796 • Number of events 40 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Acute hepatitis B
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Acute hepatitis C
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Acute sinusitis
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Anal abscess
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Anal chlamydia infection
|
17.9%
162/903 • Number of events 211 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
19.6%
176/899 • Number of events 244 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
20.8%
187/897 • Number of events 244 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
20.2%
363/1796 • Number of events 488 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Anal fistula infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Anal fungal infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Anal infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Anorectal human papilloma virus infection
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Ascariasis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Bacterial colitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Bacterial vaginosis
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Balanitis candida
|
0.33%
3/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Blastocystis infection
|
0.22%
2/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Body tinea
|
0.89%
8/903 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
10/1796 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Bronchitis
|
1.3%
12/903 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.6%
14/899 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
12/897 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.4%
26/1796 • Number of events 27 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Burn infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
COVID-19
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Cellulitis
|
0.78%
7/903 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Cestode infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Chancroid
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Chlamydial infection
|
1.00%
9/903 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
14/1796 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Cholera
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Chronic hepatitis C
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Chronic sinusitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Conjunctivitis
|
0.66%
6/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/899 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/897 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
22/1796 • Number of events 22 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Conjunctivitis viral
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Coxsackie viral infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Cystitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Dermatophytosis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Diarrhoea infectious
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Diverticulitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Dysentery
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Ear infection
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Ear infection bacterial
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Epididymitis
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Eyelid infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Febrile infection
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Folliculitis
|
1.3%
12/903 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/899 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
9/897 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
19/1796 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Fungal balanitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Fungal infection
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Fungal skin infection
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Furuncle
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gastroenteritis
|
5.3%
48/903 • Number of events 53 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.8%
43/899 • Number of events 49 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.2%
38/897 • Number of events 44 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.5%
81/1796 • Number of events 93 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gastroenteritis viral
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
12/899 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
16/1796 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gastrointestinal infection
|
0.78%
7/903 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/897 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
18/1796 • Number of events 23 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Genital candidiasis
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Genital herpes
|
0.89%
8/903 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.4%
13/899 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
23/1796 • Number of events 26 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Genital herpes simplex
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Genitourinary chlamydia infection
|
5.5%
50/903 • Number of events 54 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
5.1%
46/899 • Number of events 54 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.8%
43/897 • Number of events 46 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
5.0%
89/1796 • Number of events 100 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
3.9%
35/903 • Number of events 37 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.9%
35/899 • Number of events 42 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.0%
36/897 • Number of events 37 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.0%
71/1796 • Number of events 79 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Giardiasis
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gingivitis
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gonococcal infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Gonorrhoea
|
0.66%
6/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.61%
11/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Groin abscess
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Helicobacter gastritis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Hepatitis C
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Herpes simplex
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
9/897 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.72%
13/1796 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Herpes zoster
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Hordeolum
|
0.78%
7/903 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
14/1796 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Impetigo
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Infected bite
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Infection parasitic
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Infective corneal ulcer
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Influenza
|
1.9%
17/903 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.8%
16/899 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/897 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.5%
27/1796 • Number of events 29 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Laryngitis
|
0.33%
3/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Latent syphilis
|
2.2%
20/903 • Number of events 21 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.8%
25/899 • Number of events 28 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.1%
19/897 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.4%
44/1796 • Number of events 48 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Lice infestation
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Localised infection
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Lymphogranuloma venereum
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
53/903 • Number of events 65 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
6.1%
55/899 • Number of events 75 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
5.7%
51/897 • Number of events 72 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
5.9%
106/1796 • Number of events 147 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Nipple infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Omphalitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Onychomycosis
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Oral candidiasis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Oral herpes
|
1.1%
10/903 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
14/1796 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Oral pustule
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Orchitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
5.6%
51/903 • Number of events 61 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
7.2%
65/899 • Number of events 77 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
7.7%
69/897 • Number of events 79 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
7.5%
134/1796 • Number of events 156 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Otitis externa
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Otitis media
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Papilloma viral infection
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Paronychia
|
0.22%
2/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Parotitis
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Penile abscess
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Penile infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Periodontitis
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Perirectal abscess
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pharyngeal chlamydia infection
|
1.2%
11/903 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
12/899 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
18/1796 • Number of events 22 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pharyngitis
|
3.4%
31/903 • Number of events 34 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.8%
25/899 • Number of events 26 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.9%
26/897 • Number of events 31 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.8%
51/1796 • Number of events 57 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pharyngitis bacterial
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.3%
30/903 • Number of events 34 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.8%
25/899 • Number of events 28 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.9%
26/897 • Number of events 31 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.8%
51/1796 • Number of events 59 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pharyngotonsillitis
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pilonidal cyst
|
0.22%
2/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pneumonia
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Primary syphilis
|
0.66%
6/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/899 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.84%
15/1796 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Proctitis bacterial
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Proctitis chlamydial
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Proctitis gonococcal
|
13.7%
124/903 • Number of events 152 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
13.5%
121/899 • Number of events 151 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
13.9%
125/897 • Number of events 146 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
13.7%
246/1796 • Number of events 297 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Proctitis herpes
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Puncture site infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pustule
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Pyelonephritis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Respiratory tract infection
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Respiratory tract infection viral
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Rhinitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Schistosomiasis cutaneous
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Scrotal abscess
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Secondary syphilis
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.84%
15/1796 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Sexually transmitted disease
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Shigella infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Sinusitis
|
3.7%
33/903 • Number of events 37 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.4%
31/899 • Number of events 38 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.5%
31/897 • Number of events 36 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.5%
62/1796 • Number of events 74 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Sinusitis bacterial
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Skin bacterial infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Skin candida
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Skin infection
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Strongyloidiasis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Subcutaneous abscess
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Syphilis
|
5.8%
52/903 • Number of events 55 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
8.2%
74/899 • Number of events 79 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
8.5%
76/897 • Number of events 78 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
8.4%
150/1796 • Number of events 157 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Syphilis anal
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Syphilis genital
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tinea cruris
|
0.66%
6/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
10/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tinea faciei
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tinea infection
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tinea pedis
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/899 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.61%
11/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tinea versicolour
|
0.44%
4/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tonsillitis
|
1.2%
11/903 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
15/899 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
15/897 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
30/1796 • Number of events 32 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tonsillitis bacterial
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tooth abscess
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.61%
11/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tooth infection
|
1.2%
11/903 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/899 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
18/1796 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Upper respiratory tract infection
|
20.5%
185/903 • Number of events 285 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
17.8%
160/899 • Number of events 248 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
20.3%
182/897 • Number of events 280 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
19.0%
342/1796 • Number of events 528 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Urethral discharge syndrome
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Urethritis
|
1.4%
13/903 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.4%
22/899 • Number of events 25 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.3%
30/897 • Number of events 31 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.9%
52/1796 • Number of events 56 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Urethritis chlamydial
|
1.4%
13/903 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.3%
21/899 • Number of events 21 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
31/1796 • Number of events 31 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Urethritis gonococcal
|
1.4%
13/903 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
12/899 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
9/897 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
21/1796 • Number of events 22 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Urethritis mycoplasmal
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Urinary tract infection
|
1.2%
11/903 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/899 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
21/1796 • Number of events 22 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Vaginitis chlamydial
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Varicella
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Viral infection
|
3.0%
27/903 • Number of events 35 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.2%
38/899 • Number of events 44 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.6%
32/897 • Number of events 36 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.9%
70/1796 • Number of events 80 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Viral pharyngitis
|
0.89%
8/903 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
10/1796 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Viral rash
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Viral sinusitis
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.4%
22/903 • Number of events 26 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.8%
34/899 • Number of events 46 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.2%
29/897 • Number of events 35 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.5%
63/1796 • Number of events 81 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Vulvovaginitis gonococcal
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Wound infection
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Infections and infestations
Wound infection bacterial
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
13.0%
117/903 • Number of events 160 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
15.4%
138/899 • Number of events 194 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
14.2%
127/897 • Number of events 172 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
14.8%
265/1796 • Number of events 366 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.6%
14/903 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
14/1796 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Barotitis media
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Breast injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Burn oral cavity
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Chemical burn
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Chemical burns of eye
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.33%
3/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
13/903 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
15/899 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/897 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.4%
26/1796 • Number of events 28 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.22%
2/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Face injury
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.61%
11/1796 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Genital contusion
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Human bite
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.6%
14/903 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.0%
18/899 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.4%
25/1796 • Number of events 26 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Mallet finger
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.66%
6/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.0%
18/899 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.8%
16/897 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.9%
34/1796 • Number of events 35 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Oral contusion
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Perineal injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Peripheral nerve injury
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.55%
5/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.0%
18/897 • Number of events 23 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.4%
26/1796 • Number of events 32 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.00%
9/903 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
15/899 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
19/1796 • Number of events 21 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.2%
11/903 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.2%
20/899 • Number of events 22 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/897 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
30/1796 • Number of events 32 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Skin scar contracture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Splinter
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.55%
5/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/897 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
12/1796 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Venomous sting
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Wound
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Any Event in SOC
|
35.8%
323/903 • Number of events 659 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
36.8%
331/899 • Number of events 618 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
35.6%
319/897 • Number of events 575 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
36.2%
650/1796 • Number of events 1193 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Alanine aminotransferase increased
|
21.4%
193/903 • Number of events 321 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
20.8%
187/899 • Number of events 282 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
19.2%
172/897 • Number of events 265 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
20.0%
359/1796 • Number of events 547 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Amylase increased
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
26/903 • Number of events 37 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.3%
21/899 • Number of events 29 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.5%
22/897 • Number of events 28 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.4%
43/1796 • Number of events 57 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood albumin decreased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood bicarbonate decreased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood bilirubin increased
|
0.66%
6/903 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/899 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
12/1796 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood cholesterol increased
|
0.33%
3/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood creatine increased
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.22%
2/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood creatinine increased
|
11.7%
106/903 • Number of events 146 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
11.2%
101/899 • Number of events 141 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
13.0%
117/897 • Number of events 152 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
12.1%
218/1796 • Number of events 293 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood glucose decreased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood glucose increased
|
0.78%
7/903 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/899 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
12/897 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
23/1796 • Number of events 30 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood potassium decreased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood potassium increased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood pressure increased
|
3.5%
32/903 • Number of events 51 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.8%
34/899 • Number of events 48 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.1%
28/897 • Number of events 46 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.5%
62/1796 • Number of events 94 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood testosterone decreased
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood triglycerides increased
|
0.33%
3/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood uric acid increased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Blood urine present
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Body temperature increased
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Cardiac murmur
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Creatinine renal clearance increased
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Eosinophil count increased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Glomerular filtration rate abnormal
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Haemoglobin decreased
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.72%
13/1796 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Heart rate increased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
International normalised ratio increased
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Low density lipoprotein increased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Lymph node palpable
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Lymphocyte count decreased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Neutrophil count decreased
|
1.8%
16/903 • Number of events 21 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.0%
27/899 • Number of events 43 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.6%
14/897 • Number of events 22 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.3%
41/1796 • Number of events 65 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Platelet count decreased
|
0.78%
7/903 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.72%
13/1796 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Prostatic specific antigen increased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Protein urine present
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Prothrombin time prolonged
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Red blood cell schistocytes present
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Red blood cells urine
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Transaminases increased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
Vitamin D decreased
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Investigations
White blood cell count decreased
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Any Event in SOC
|
1.3%
12/903 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.2%
20/899 • Number of events 21 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.9%
17/897 • Number of events 21 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.1%
37/1796 • Number of events 42 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Dairy intolerance
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Gout
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
10.7%
97/903 • Number of events 130 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
13.5%
121/899 • Number of events 160 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
10.6%
95/897 • Number of events 143 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
12.0%
216/1796 • Number of events 303 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Ankle impingement
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
24/903 • Number of events 26 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.8%
34/899 • Number of events 36 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.3%
30/897 • Number of events 34 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.6%
64/1796 • Number of events 70 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
33/903 • Number of events 34 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.0%
27/899 • Number of events 30 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.5%
31/897 • Number of events 36 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.2%
58/1796 • Number of events 66 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.33%
3/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Joint hyperextension
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
13/903 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.2%
20/899 • Number of events 24 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/897 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
31/1796 • Number of events 35 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
9/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/897 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.95%
17/1796 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
15/903 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.8%
16/899 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.3%
21/897 • Number of events 22 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.1%
37/1796 • Number of events 39 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.66%
6/903 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC
|
2.1%
19/903 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.0%
18/899 • Number of events 21 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.4%
13/897 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
31/1796 • Number of events 35 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal neoplasm
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
1.00%
9/903 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/897 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.84%
15/1796 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of testis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile wart
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Any Event in SOC
|
5.2%
47/903 • Number of events 56 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
7.2%
65/899 • Number of events 78 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
6.8%
61/897 • Number of events 76 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
7.0%
126/1796 • Number of events 154 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Altered state of consciousness
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Bell's palsy
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Circadian rhythm sleep disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Disturbance in attention
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Dizziness
|
0.66%
6/903 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
9/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
14/1796 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Headache
|
2.4%
22/903 • Number of events 22 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.6%
23/899 • Number of events 25 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.0%
27/897 • Number of events 33 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.8%
50/1796 • Number of events 58 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Hypoaesthesia
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Hypotonia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Migraine
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Nerve compression
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Nerve degeneration
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Paraesthesia
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Parosmia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Polyneuropathy
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Presyncope
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/899 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
16/1796 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Sciatica
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Seizure
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Sensory loss
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Syncope
|
0.22%
2/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Nervous system disorders
Tension headache
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Product Issues
Any Event in SOC
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Product Issues
Device dislocation
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Any Event in SOC
|
6.2%
56/903 • Number of events 78 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
6.2%
56/899 • Number of events 73 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
6.5%
58/897 • Number of events 75 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
6.3%
114/1796 • Number of events 148 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Alcohol abuse
|
0.44%
4/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Alcohol use disorder
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Anxiety
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.8%
16/899 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.4%
13/897 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.6%
29/1796 • Number of events 29 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Apathy
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Bipolar II disorder
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Bipolar disorder
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Borderline personality disorder
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Bruxism
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Depressed mood
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Depression
|
1.7%
15/903 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.1%
19/899 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.1%
19/897 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.1%
38/1796 • Number of events 39 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Drug abuse
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Grief reaction
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Hypomania
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Insomnia
|
1.2%
11/903 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/897 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
16/1796 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Intentional self-injury
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Irritability
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Libido decreased
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Major depression
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Mental disorder
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Mood altered
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Nightmare
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Panic attack
|
0.33%
3/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Panic disorder
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Psychotic disorder
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Seasonal affective disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Sleep disorder
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Social anxiety disorder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Stress
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Substance abuse
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Suicidal ideation
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
4/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Psychiatric disorders
Tic
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Any Event in SOC
|
9.6%
87/903 • Number of events 106 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
9.6%
86/899 • Number of events 117 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
10.1%
91/897 • Number of events 109 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
9.9%
177/1796 • Number of events 226 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Dysuria
|
1.8%
16/903 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.0%
18/899 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.3%
12/897 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
30/1796 • Number of events 32 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Glycosuria
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Haematuria
|
3.2%
29/903 • Number of events 32 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.8%
34/899 • Number of events 43 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.1%
28/897 • Number of events 36 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.5%
62/1796 • Number of events 79 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Micturition urgency
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/899 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
9/897 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.84%
15/1796 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Proteinuria
|
3.2%
29/903 • Number of events 35 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.1%
19/899 • Number of events 23 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.1%
28/897 • Number of events 30 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.6%
47/1796 • Number of events 53 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Renal colic
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Sterile pyuria
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Urethral discharge
|
0.89%
8/903 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/897 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
19/1796 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Urethral pain
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Urinary retention
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Renal and urinary disorders
Urine abnormality
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Any Event in SOC
|
4.4%
40/903 • Number of events 45 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.4%
31/899 • Number of events 33 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
4.1%
37/897 • Number of events 42 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.8%
68/1796 • Number of events 75 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
9/897 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
14/1796 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Galactorrhoea
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Genital discharge
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Genital erythema
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Genital macule
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Genital odour
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Genital paraesthesia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Genital rash
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Genital ulceration
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Haematospermia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Nipple inflammation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Penile blister
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Penile discharge
|
1.00%
9/903 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
12/1796 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Penile erythema
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Penile pain
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Penile rash
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Penis disorder
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Perineal rash
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Prostatitis
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Scrotal dermatitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Testicular mass
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Testicular pain
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
8.4%
76/903 • Number of events 91 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
7.7%
69/899 • Number of events 87 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
8.9%
80/897 • Number of events 100 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
8.3%
149/1796 • Number of events 187 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic pharyngitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.44%
4/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/899 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.7%
15/897 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.4%
26/1796 • Number of events 28 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.11%
1/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity mass
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.72%
13/1796 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal blistering
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discolouration
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
25/903 • Number of events 26 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.7%
24/899 • Number of events 28 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.2%
29/897 • Number of events 35 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.0%
53/1796 • Number of events 63 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.66%
6/903 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.39%
7/1796 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
6/1796 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar cyst
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar erythema
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord inflammation
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord thickening
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
11.1%
100/903 • Number of events 121 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
15.1%
136/899 • Number of events 165 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
13.2%
118/897 • Number of events 146 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
14.1%
254/1796 • Number of events 311 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
10/899 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.72%
13/1796 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Acute cutaneous lupus erythematosus
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.44%
4/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Androgenetic alopecia
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
10/1796 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.4%
13/903 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.2%
20/899 • Number of events 20 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.8%
16/897 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.0%
36/1796 • Number of events 37 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/899 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.45%
8/1796 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.33%
3/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/897 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.61%
11/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.2%
11/897 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.1%
19/1796 • Number of events 23 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.89%
8/903 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
11/903 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.3%
21/899 • Number of events 22 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.6%
28/1796 • Number of events 29 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/899 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
10/1796 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.55%
5/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.28%
5/1796 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.44%
4/903 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.56%
5/897 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.44%
4/903 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.78%
7/897 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.61%
11/1796 • Number of events 11 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.22%
2/903 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
2/1796 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.44%
4/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/899 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
4/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/899 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.3%
12/903 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.8%
16/899 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.5%
22/897 • Number of events 26 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
2.1%
38/1796 • Number of events 42 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Vascular disorders
Any Event in SOC
|
1.8%
16/903 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
1.0%
9/899 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.89%
8/897 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.95%
17/1796 • Number of events 18 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Vascular disorders
Flushing
|
0.22%
2/903 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Vascular disorders
Haematoma
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Vascular disorders
Hot flush
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Vascular disorders
Hypertension
|
1.4%
13/903 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.67%
6/899 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.33%
3/897 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.50%
9/1796 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Vascular disorders
Hypotension
|
0.11%
1/903 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1796 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.22%
2/897 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.17%
3/1796 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/899 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/897 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/903 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/899 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.11%
1/897 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.06%
1/1796 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place