Trial Outcomes & Findings for Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women (NCT NCT02568215)
NCT ID: NCT02568215
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
1924 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
|
637
|
642
|
645
|
|
Overall Study
Modified Intent-to-treat Population
|
637
|
642
|
645
|
|
Overall Study
COMPLETED
|
558
|
562
|
555
|
|
Overall Study
NOT COMPLETED
|
79
|
80
|
90
|
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
|
1
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
29
|
32
|
41
|
|
Overall Study
Withdrawal by Subject
|
21
|
19
|
22
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Participant Unable to Adhere to Visit Schedule
|
25
|
23
|
21
|
|
Overall Study
Other
|
0
|
1
|
4
|
Baseline Characteristics
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
Baseline characteristics by cohort
| Measure |
Placebo
n=637 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=642 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=645 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=1924 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26 years
n=5 Participants
|
25 years
n=7 Participants
|
26 years
n=5 Participants
|
25 years
n=4 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
18 - 20 years
|
84 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
|
Age, Customized
21 - 30 years
|
408 Participants
n=5 Participants
|
416 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
1235 Participants
n=4 Participants
|
|
Age, Customized
31 - 40 years
|
142 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
420 Participants
n=4 Participants
|
|
Age, Customized
41 - 50 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
637 Participants
n=5 Participants
|
642 Participants
n=7 Participants
|
645 Participants
n=5 Participants
|
1924 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
637 Participants
n=5 Participants
|
642 Participants
n=7 Participants
|
645 Participants
n=5 Participants
|
1924 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
628 Participants
n=5 Participants
|
635 Participants
n=7 Participants
|
639 Participants
n=5 Participants
|
1902 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Indian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Colored/Mixed
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Mozambique
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
Malawi
|
59 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Region of Enrollment
Botswana
|
47 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Region of Enrollment
Tanzania
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
340 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
1019 Participants
n=4 Participants
|
|
Region of Enrollment
Zimbabwe
|
145 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
434 Participants
n=4 Participants
|
|
Region of Enrollment
Kenya
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
82 Participants
n=4 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=637 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=642 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=645 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=1287 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
|
476 Participants
|
496 Participants
|
506 Participants
|
1002 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Mild
|
142 Participants
|
120 Participants
|
120 Participants
|
240 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Moderate
|
19 Participants
|
26 Participants
|
16 Participants
|
42 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Severe
|
0 Participants
|
0 Participants
|
3 Participants
|
3 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
|
518 Participants
|
547 Participants
|
543 Participants
|
1090 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Mild
|
104 Participants
|
81 Participants
|
87 Participants
|
168 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Moderate
|
15 Participants
|
13 Participants
|
13 Participants
|
26 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Severe
|
0 Participants
|
1 Participants
|
2 Participants
|
3 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
|
452 Participants
|
482 Participants
|
476 Participants
|
958 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Mild
|
162 Participants
|
133 Participants
|
144 Participants
|
277 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Moderate
|
23 Participants
|
26 Participants
|
22 Participants
|
48 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Severe
|
0 Participants
|
1 Participants
|
3 Participants
|
4 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=637 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=642 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=645 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=1287 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 4: Potentially Life-Threatening complication
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None or Not Gradable
|
618 Participants
|
618 Participants
|
629 Participants
|
1247 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim.
|
12 Participants
|
17 Participants
|
12 Participants
|
29 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim.
|
7 Participants
|
7 Participants
|
4 Participants
|
11 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication
|
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: Potentially Life-Threatening complication
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · None or Not Gradable
|
623 Participants
|
632 Participants
|
639 Participants
|
1271 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim.
|
12 Participants
|
9 Participants
|
5 Participants
|
14 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim.
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication
|
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: Potentially Life-Threatening complication
|
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 or Not Gradable
|
610 Participants
|
612 Participants
|
627 Participants
|
1239 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 1: 6.25 to less than 25 sq.cm or 2.5 to less than 5 cm single dim.
|
20 Participants
|
22 Participants
|
13 Participants
|
35 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 2: 25 to less than 100 sq.cm or 5 to less than 10 cm single dim.
|
7 Participants
|
8 Participants
|
5 Participants
|
13 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: >=100 sq.cm or >=10 cm single dim or severe complication
|
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=637 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=642 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=645 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=1287 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
Increased Body Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
43 Participants
|
54 Participants
|
36 Participants
|
90 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
17 Participants
|
12 Participants
|
13 Participants
|
25 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
|
319 Participants
|
328 Participants
|
326 Participants
|
654 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
246 Participants
|
230 Participants
|
233 Participants
|
463 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
72 Participants
|
84 Participants
|
85 Participants
|
169 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
1 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
|
609 Participants
|
610 Participants
|
616 Participants
|
1226 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased Body Temperature · Mild
|
15 Participants
|
14 Participants
|
20 Participants
|
34 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased Body Temperature · Moderate
|
10 Participants
|
16 Participants
|
7 Participants
|
23 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Increased Body Temperature · Severe
|
3 Participants
|
2 Participants
|
2 Participants
|
4 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
Malaise and/or fatigue · None
|
473 Participants
|
487 Participants
|
495 Participants
|
982 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
134 Participants
|
122 Participants
|
107 Participants
|
229 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
30 Participants
|
33 Participants
|
42 Participants
|
75 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 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
|
561 Participants
|
574 Participants
|
579 Participants
|
1153 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
57 Participants
|
50 Participants
|
54 Participants
|
104 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
19 Participants
|
18 Participants
|
12 Participants
|
30 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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
|
382 Participants
|
394 Participants
|
387 Participants
|
781 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
198 Participants
|
182 Participants
|
188 Participants
|
370 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
57 Participants
|
66 Participants
|
70 Participants
|
136 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
549 Participants
|
565 Participants
|
567 Participants
|
1132 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
76 Participants
|
70 Participants
|
65 Participants
|
135 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
12 Participants
|
7 Participants
|
13 Participants
|
20 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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
|
603 Participants
|
611 Participants
|
614 Participants
|
1225 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Mild
|
26 Participants
|
28 Participants
|
28 Participants
|
56 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
|
8 Participants
|
3 Participants
|
3 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
|
589 Participants
|
591 Participants
|
599 Participants
|
1190 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
40 Participants
|
43 Participants
|
37 Participants
|
80 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
8 Participants
|
8 Participants
|
9 Participants
|
17 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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
|
577 Participants
|
576 Participants
|
596 Participants
|
1172 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=637 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=642 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=645 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=1287 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
|
15 U/L
Interval 12.0 to 21.0
|
15 U/L
Interval 12.0 to 20.0
|
16 U/L
Interval 12.0 to 22.0
|
15 U/L
Interval 12.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 8
|
15 U/L
Interval 12.0 to 21.0
|
15 U/L
Interval 11.0 to 20.0
|
16 U/L
Interval 12.0 to 22.0
|
15 U/L
Interval 12.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 16
|
16 U/L
Interval 12.0 to 22.0
|
15 U/L
Interval 11.0 to 20.0
|
16 U/L
Interval 12.0 to 21.0
|
15 U/L
Interval 12.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 24
|
16 U/L
Interval 12.0 to 22.0
|
14 U/L
Interval 11.0 to 20.0
|
16 U/L
Interval 12.0 to 21.0
|
15 U/L
Interval 12.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 32
|
16 U/L
Interval 12.0 to 22.0
|
15 U/L
Interval 12.0 to 21.0
|
16 U/L
Interval 12.0 to 21.5
|
16 U/L
Interval 12.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 40
|
16 U/L
Interval 12.0 to 23.0
|
15 U/L
Interval 11.0 to 21.0
|
15 U/L
Interval 12.0 to 22.0
|
15 U/L
Interval 12.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 48
|
16 U/L
Interval 12.0 to 22.0
|
15 U/L
Interval 12.0 to 21.0
|
16 U/L
Interval 12.0 to 21.0
|
15 U/L
Interval 12.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 56
|
16 U/L
Interval 12.0 to 22.0
|
15 U/L
Interval 12.0 to 20.0
|
16 U/L
Interval 12.0 to 21.0
|
16 U/L
Interval 12.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 64
|
16 U/L
Interval 12.0 to 22.0
|
15 U/L
Interval 12.0 to 20.0
|
15 U/L
Interval 12.0 to 21.0
|
15 U/L
Interval 12.0 to 20.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
ALT (SGPT) (U/L)- Week 72
|
16 U/L
Interval 12.0 to 21.0
|
15 U/L
Interval 12.0 to 20.0
|
15 U/L
Interval 12.0 to 20.0
|
15 U/L
Interval 12.0 to 20.0
|
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=637 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=642 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=645 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=1287 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
|
0.64 mg/dL
Interval 0.59 to 0.72
|
0.66 mg/dL
Interval 0.6 to 0.73
|
0.67 mg/dL
Interval 0.59 to 0.72
|
0.66 mg/dL
Interval 0.6 to 0.73
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 8
|
0.65 mg/dL
Interval 0.59 to 0.73
|
0.66 mg/dL
Interval 0.6 to 0.72
|
0.66 mg/dL
Interval 0.59 to 0.73
|
0.66 mg/dL
Interval 0.59 to 0.73
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 16
|
0.66 mg/dL
Interval 0.6 to 0.72
|
0.66 mg/dL
Interval 0.6 to 0.74
|
0.67 mg/dL
Interval 0.6 to 0.75
|
0.67 mg/dL
Interval 0.6 to 0.74
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 24
|
0.67 mg/dL
Interval 0.6 to 0.74
|
0.68 mg/dL
Interval 0.61 to 0.74
|
0.67 mg/dL
Interval 0.6 to 0.74
|
0.67 mg/dL
Interval 0.6 to 0.74
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 32
|
0.66 mg/dL
Interval 0.6 to 0.74
|
0.67 mg/dL
Interval 0.6 to 0.74
|
0.67 mg/dL
Interval 0.6 to 0.75
|
0.67 mg/dL
Interval 0.6 to 0.75
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 40
|
0.67 mg/dL
Interval 0.6 to 0.75
|
0.67 mg/dL
Interval 0.6 to 0.75
|
0.68 mg/dL
Interval 0.6 to 0.75
|
0.67 mg/dL
Interval 0.6 to 0.75
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 48
|
0.67 mg/dL
Interval 0.59 to 0.75
|
0.67 mg/dL
Interval 0.6 to 0.75
|
0.68 mg/dL
Interval 0.61 to 0.75
|
0.68 mg/dL
Interval 0.6 to 0.75
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 56
|
0.67 mg/dL
Interval 0.6 to 0.74
|
0.67 mg/dL
Interval 0.61 to 0.76
|
0.68 mg/dL
Interval 0.61 to 0.75
|
0.68 mg/dL
Interval 0.61 to 0.76
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 64
|
0.67 mg/dL
Interval 0.61 to 0.75
|
0.68 mg/dL
Interval 0.6 to 0.75
|
0.68 mg/dL
Interval 0.62 to 0.76
|
0.68 mg/dL
Interval 0.61 to 0.75
|
|
Chemistry and Hematology Laboratory Measures - Creatinine
Creatinine (mg/dL)- Week 72
|
0.67 mg/dL
Interval 0.61 to 0.74
|
0.68 mg/dL
Interval 0.61 to 0.74
|
0.68 mg/dL
Interval 0.61 to 0.75
|
0.68 mg/dL
Interval 0.61 to 0.75
|
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=637 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=642 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=645 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=1287 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
|
13.4 g/dL
Interval 12.6 to 14.2
|
13.4 g/dL
Interval 12.7 to 14.2
|
13.6 g/dL
Interval 12.8 to 14.3
|
13.5 g/dL
Interval 12.7 to 14.3
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 8
|
13.2 g/dL
Interval 12.6 to 13.9
|
13.2 g/dL
Interval 12.5 to 13.9
|
13.3 g/dL
Interval 12.45 to 14.1
|
13.2 g/dL
Interval 12.5 to 14.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 16
|
13.2 g/dL
Interval 12.4 to 13.9
|
13.1 g/dL
Interval 12.2 to 13.9
|
13.2 g/dL
Interval 12.3 to 13.9
|
13.1 g/dL
Interval 12.3 to 13.9
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 24
|
13.1 g/dL
Interval 12.4 to 13.9
|
13.1 g/dL
Interval 12.3 to 13.8
|
13.1 g/dL
Interval 12.4 to 13.9
|
13.1 g/dL
Interval 12.3 to 13.9
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 32
|
13.1 g/dL
Interval 12.3 to 13.9
|
13.1 g/dL
Interval 12.3 to 13.8
|
13.2 g/dL
Interval 12.3 to 13.9
|
13.1 g/dL
Interval 12.3 to 13.9
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 40
|
13.1 g/dL
Interval 12.3 to 13.9
|
13.15 g/dL
Interval 12.3 to 13.9
|
13.2 g/dL
Interval 12.3 to 14.0
|
13.2 g/dL
Interval 12.3 to 13.9
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 48
|
13 g/dL
Interval 12.3 to 13.9
|
13.1 g/dL
Interval 12.2 to 13.8
|
13.2 g/dL
Interval 12.4 to 13.9
|
13.1 g/dL
Interval 12.3 to 13.9
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 56
|
13.1 g/dL
Interval 12.3 to 13.9
|
13 g/dL
Interval 12.2 to 13.8
|
13.1 g/dL
Interval 12.4 to 13.8
|
13.1 g/dL
Interval 12.3 to 13.8
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 64
|
13 g/dL
Interval 12.3 to 13.8
|
13 g/dL
Interval 12.3 to 13.8
|
13.1 g/dL
Interval 12.4 to 13.9
|
13.1 g/dL
Interval 12.3 to 13.8
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin
Hemoglobin (g/dL)- Week 72
|
13 g/dL
Interval 12.15 to 13.8
|
13 g/dL
Interval 12.2 to 13.8
|
13.1 g/dL
Interval 12.3 to 13.9
|
13 g/dL
Interval 12.2 to 13.8
|
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=637 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=642 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=645 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=1287 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
|
2172 cells/cubic mm
Interval 1820.0 to 2560.0
|
2123 cells/cubic mm
Interval 1799.0 to 2540.0
|
2180 cells/cubic mm
Interval 1848.0 to 2570.0
|
2160 cells/cubic mm
Interval 1822.0 to 2560.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 8
|
2148 cells/cubic mm
Interval 1810.0 to 2490.0
|
2050 cells/cubic mm
Interval 1742.0 to 2424.0
|
2145.5 cells/cubic mm
Interval 1819.5 to 2514.0
|
2100 cells/cubic mm
Interval 1770.0 to 2478.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 16
|
2120 cells/cubic mm
Interval 1760.0 to 2487.0
|
2060 cells/cubic mm
Interval 1772.0 to 2408.0
|
2082.5 cells/cubic mm
Interval 1750.0 to 2450.0
|
2070 cells/cubic mm
Interval 1765.0 to 2430.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 24
|
2124.5 cells/cubic mm
Interval 1788.0 to 2460.0
|
2042 cells/cubic mm
Interval 1730.0 to 2400.0
|
2091 cells/cubic mm
Interval 1747.0 to 2472.0
|
2067 cells/cubic mm
Interval 1739.0 to 2428.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 32
|
2125.5 cells/cubic mm
Interval 1785.0 to 2489.0
|
2040 cells/cubic mm
Interval 1740.0 to 2449.0
|
2074.5 cells/cubic mm
Interval 1792.0 to 2470.0
|
2060 cells/cubic mm
Interval 1752.0 to 2458.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 40
|
2110.5 cells/cubic mm
Interval 1761.5 to 2457.0
|
2052 cells/cubic mm
Interval 1720.0 to 2451.0
|
2110 cells/cubic mm
Interval 1736.0 to 2470.0
|
2080 cells/cubic mm
Interval 1723.0 to 2459.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 48
|
2111 cells/cubic mm
Interval 1781.0 to 2448.0
|
2042 cells/cubic mm
Interval 1720.0 to 2396.0
|
2148 cells/cubic mm
Interval 1790.0 to 2504.0
|
2080 cells/cubic mm
Interval 1751.0 to 2457.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 56
|
2082.5 cells/cubic mm
Interval 1765.0 to 2460.5
|
2000 cells/cubic mm
Interval 1734.0 to 2400.0
|
2120.5 cells/cubic mm
Interval 1760.0 to 2487.0
|
2051 cells/cubic mm
Interval 1750.0 to 2436.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 64
|
2070 cells/cubic mm
Interval 1740.0 to 2434.0
|
2029 cells/cubic mm
Interval 1710.0 to 2379.0
|
2106 cells/cubic mm
Interval 1780.0 to 2470.0
|
2068.5 cells/cubic mm
Interval 1740.0 to 2430.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Lymphocytes (cells/cubic mm)- Week 72
|
2109.5 cells/cubic mm
Interval 1757.0 to 2459.5
|
2040 cells/cubic mm
Interval 1720.0 to 2420.0
|
2150 cells/cubic mm
Interval 1772.0 to 2447.0
|
2090 cells/cubic mm
Interval 1747.0 to 2431.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 0
|
3008 cells/cubic mm
Interval 2300.0 to 4113.0
|
2999 cells/cubic mm
Interval 2358.0 to 3950.0
|
3200 cells/cubic mm
Interval 2458.0 to 4147.0
|
3107.5 cells/cubic mm
Interval 2404.5 to 4051.5
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 8
|
2940.5 cells/cubic mm
Interval 2215.0 to 3930.0
|
2905.5 cells/cubic mm
Interval 2190.0 to 3750.0
|
3070 cells/cubic mm
Interval 2340.0 to 3980.0
|
2985 cells/cubic mm
Interval 2270.0 to 3859.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 16
|
2868.5 cells/cubic mm
Interval 2110.0 to 3834.0
|
2821 cells/cubic mm
Interval 2190.0 to 3760.0
|
3046.5 cells/cubic mm
Interval 2310.0 to 3976.0
|
2950 cells/cubic mm
Interval 2260.0 to 3900.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 24
|
2858 cells/cubic mm
Interval 2188.0 to 3930.0
|
2924 cells/cubic mm
Interval 2213.0 to 3800.0
|
2922 cells/cubic mm
Interval 2265.0 to 3960.0
|
2923 cells/cubic mm
Interval 2240.0 to 3900.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 32
|
2830 cells/cubic mm
Interval 2117.5 to 3863.5
|
2881 cells/cubic mm
Interval 2200.0 to 3969.0
|
2988 cells/cubic mm
Interval 2320.0 to 3931.0
|
2943 cells/cubic mm
Interval 2239.0 to 3956.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 40
|
2910 cells/cubic mm
Interval 2215.0 to 3939.0
|
2888.5 cells/cubic mm
Interval 2224.0 to 3779.0
|
3065 cells/cubic mm
Interval 2319.0 to 4062.5
|
3020.5 cells/cubic mm
Interval 2253.0 to 3905.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 48
|
2920 cells/cubic mm
Interval 2187.0 to 3910.0
|
2990 cells/cubic mm
Interval 2271.0 to 3908.0
|
2994 cells/cubic mm
Interval 2249.0 to 3956.0
|
2992.5 cells/cubic mm
Interval 2263.0 to 3930.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 56
|
3000 cells/cubic mm
Interval 2261.0 to 4045.0
|
2940 cells/cubic mm
Interval 2206.0 to 3846.0
|
2955.5 cells/cubic mm
Interval 2280.0 to 3830.0
|
2945 cells/cubic mm
Interval 2240.0 to 3846.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 64
|
2834 cells/cubic mm
Interval 2125.0 to 3908.0
|
2918 cells/cubic mm
Interval 2198.0 to 3862.0
|
2970 cells/cubic mm
Interval 2316.0 to 3870.0
|
2944 cells/cubic mm
Interval 2244.0 to 3866.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
Neutrophils (cells/cubic mm)- Week 72
|
2868.5 cells/cubic mm
Interval 2164.5 to 3836.0
|
2880 cells/cubic mm
Interval 2230.0 to 3726.0
|
2970 cells/cubic mm
Interval 2290.0 to 3829.0
|
2920 cells/cubic mm
Interval 2254.0 to 3770.0
|
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=637 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=642 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=645 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=1287 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)
WBC (1000 cells/cubic mm)- Week 0
|
5.76 1000 cells/cubic mm
Interval 4.8 to 7.1
|
5.76 1000 cells/cubic mm
Interval 4.9 to 6.87
|
6.1 1000 cells/cubic mm
Interval 5.07 to 7.14
|
5.9 1000 cells/cubic mm
Interval 5.0 to 7.02
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 8
|
5.72 1000 cells/cubic mm
Interval 4.75 to 6.91
|
5.55 1000 cells/cubic mm
Interval 4.7 to 6.63
|
5.75 1000 cells/cubic mm
Interval 4.92 to 6.99
|
5.63 1000 cells/cubic mm
Interval 4.8 to 6.8
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 16
|
5.54 1000 cells/cubic mm
Interval 4.57 to 6.9
|
5.53 1000 cells/cubic mm
Interval 4.63 to 6.7
|
5.71 1000 cells/cubic mm
Interval 4.82 to 6.93
|
5.63 1000 cells/cubic mm
Interval 4.72 to 6.83
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 24
|
5.57 1000 cells/cubic mm
Interval 4.66 to 6.81
|
5.58 1000 cells/cubic mm
Interval 4.66 to 6.64
|
5.6 1000 cells/cubic mm
Interval 4.72 to 6.85
|
5.6 1000 cells/cubic mm
Interval 4.7 to 6.76
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 32
|
5.6 1000 cells/cubic mm
Interval 4.57 to 6.9
|
5.6 1000 cells/cubic mm
Interval 4.6 to 6.83
|
5.76 1000 cells/cubic mm
Interval 4.84 to 6.91
|
5.69 1000 cells/cubic mm
Interval 4.73 to 6.86
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 40
|
5.6 1000 cells/cubic mm
Interval 4.65 to 6.71
|
5.6 1000 cells/cubic mm
Interval 4.73 to 6.7
|
5.75 1000 cells/cubic mm
Interval 4.78 to 6.89
|
5.67 1000 cells/cubic mm
Interval 4.77 to 6.81
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 48
|
5.6 1000 cells/cubic mm
Interval 4.63 to 6.8
|
5.64 1000 cells/cubic mm
Interval 4.77 to 6.7
|
5.79 1000 cells/cubic mm
Interval 4.73 to 7.0
|
5.69 1000 cells/cubic mm
Interval 4.75 to 6.9
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 56
|
5.65 1000 cells/cubic mm
Interval 4.67 to 7.01
|
5.54 1000 cells/cubic mm
Interval 4.6 to 6.8
|
5.62 1000 cells/cubic mm
Interval 4.7 to 6.8
|
5.6 1000 cells/cubic mm
Interval 4.67 to 6.8
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 64
|
5.52 1000 cells/cubic mm
Interval 4.6 to 6.87
|
5.6 1000 cells/cubic mm
Interval 4.65 to 6.54
|
5.62 1000 cells/cubic mm
Interval 4.77 to 6.83
|
5.61 1000 cells/cubic mm
Interval 4.7 to 6.69
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
WBC (1000 cells/cubic mm)- Week 72
|
5.57 1000 cells/cubic mm
Interval 4.58 to 6.88
|
5.57 1000 cells/cubic mm
Interval 4.68 to 6.59
|
5.77 1000 cells/cubic mm
Interval 4.73 to 6.89
|
5.66 1000 cells/cubic mm
Interval 4.7 to 6.7
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 0
|
272 1000 cells/cubic mm
Interval 227.0 to 315.0
|
275 1000 cells/cubic mm
Interval 234.0 to 322.0
|
279 1000 cells/cubic mm
Interval 240.0 to 323.0
|
277 1000 cells/cubic mm
Interval 236.0 to 322.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 8
|
271 1000 cells/cubic mm
Interval 230.0 to 317.0
|
275 1000 cells/cubic mm
Interval 234.0 to 318.0
|
282 1000 cells/cubic mm
Interval 238.0 to 323.0
|
279 1000 cells/cubic mm
Interval 236.0 to 321.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 16
|
275 1000 cells/cubic mm
Interval 232.0 to 320.0
|
275 1000 cells/cubic mm
Interval 235.0 to 322.0
|
280 1000 cells/cubic mm
Interval 241.0 to 329.0
|
278 1000 cells/cubic mm
Interval 238.0 to 326.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 24
|
277 1000 cells/cubic mm
Interval 233.0 to 315.0
|
278 1000 cells/cubic mm
Interval 233.0 to 323.0
|
283 1000 cells/cubic mm
Interval 240.0 to 330.5
|
280 1000 cells/cubic mm
Interval 238.0 to 326.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 32
|
272 1000 cells/cubic mm
Interval 231.0 to 314.5
|
277 1000 cells/cubic mm
Interval 236.0 to 327.0
|
285 1000 cells/cubic mm
Interval 243.0 to 326.0
|
282 1000 cells/cubic mm
Interval 240.0 to 327.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 40
|
276 1000 cells/cubic mm
Interval 233.0 to 324.0
|
281 1000 cells/cubic mm
Interval 238.0 to 323.0
|
285 1000 cells/cubic mm
Interval 241.0 to 331.0
|
283 1000 cells/cubic mm
Interval 239.0 to 329.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 48
|
270 1000 cells/cubic mm
Interval 235.0 to 320.0
|
279 1000 cells/cubic mm
Interval 236.0 to 324.0
|
282 1000 cells/cubic mm
Interval 246.0 to 333.0
|
281 1000 cells/cubic mm
Interval 240.0 to 329.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 56
|
274 1000 cells/cubic mm
Interval 231.0 to 324.0
|
274 1000 cells/cubic mm
Interval 235.0 to 323.0
|
280 1000 cells/cubic mm
Interval 238.0 to 329.0
|
277 1000 cells/cubic mm
Interval 237.0 to 326.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 64
|
271.5 1000 cells/cubic mm
Interval 231.5 to 319.0
|
274 1000 cells/cubic mm
Interval 237.0 to 325.0
|
282 1000 cells/cubic mm
Interval 240.0 to 323.0
|
277 1000 cells/cubic mm
Interval 238.0 to 324.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
Platelets (1000 cells/cubic mm)- Week 72
|
274 1000 cells/cubic mm
Interval 234.5 to 326.0
|
276.5 1000 cells/cubic mm
Interval 238.0 to 323.0
|
281 1000 cells/cubic mm
Interval 239.0 to 329.0
|
278.5 1000 cells/cubic mm
Interval 238.0 to 325.0
|
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=637 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=642 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=645 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=1287 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
Creatinine (mg/dL)- Week 32
|
6 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 8
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 32
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 40
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 56
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
ALT (SGPT) (U/L)- Week 64
|
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 72
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 8
|
1 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
|
1 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
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 56
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 64
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Hemoglobin (g/dL)- Week 72
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 8
|
5 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 16
|
2 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 24
|
2 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 40
|
7 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 48
|
3 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 56
|
5 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 64
|
4 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Creatinine (mg/dL)- Week 72
|
7 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
WBC (1000 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
WBC (1000 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
WBC (1000 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
WBC (1000 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
WBC (1000 cells/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 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
WBC (1000 cells/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 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
WBC (1000 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
Platelets (1000 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
Platelets (1000 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
Platelets (1000 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
Platelets (1000 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
Platelets (1000 cells/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 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
Platelets (1000 cells/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 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
Platelets (1000 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
Lymphocytes (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
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
|
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 32
|
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 40
|
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
Lymphocytes (cells/cubic mm)- Week 48
|
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 56
|
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 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 8
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Chemistry and Hematology Laboratory Measures Meeting Grade 3 AE Criteria or Above
Neutrophils (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
Neutrophils (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
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
|
0 Participants
|
0 Participants
|
0 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
|
0 Participants
|
0 Participants
|
0 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=637 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=642 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=645 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=1287 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
Pregnancy
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
HIV infection
|
28 Participants
|
25 Participants
|
15 Participants
|
40 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Clinical event other than reactogenicity
|
3 Participants
|
16 Participants
|
24 Participants
|
40 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Reactogenicity Symptom
|
0 Participants
|
6 Participants
|
2 Participants
|
8 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Investigator Reason
|
4 Participants
|
2 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Participant refused study product infusion
|
2 Participants
|
4 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Co-enrollment in a study
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Two(2) reactive HIV tests
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Other
|
6 Participants
|
8 Participants
|
10 Participants
|
18 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
Termination from study for non-medical reason(s)
|
30 Participants
|
32 Participants
|
26 Participants
|
58 Participants
|
|
Number of Participants With Early Infusion Discontinuation and Reasons for Discontinuation
No Discontinuation
|
560 Participants
|
545 Participants
|
554 Participants
|
1099 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=637 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=642 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=645 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
|
5.3 events per 100 person years
Interval 3.9 to 7.1
|
8.7 events per 100 person years
Interval 6.9 to 10.9
|
8 events per 100 person years
Interval 6.3 to 10.2
|
—
|
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=637 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=642 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=645 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=1287 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
|
29 Participants
|
28 Participants
|
19 Participants
|
47 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=11 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
|
19.8 μg/ml
Interval 12.7 to 27.2
|
44.7 μg/ml
Interval 29.4 to 80.5
|
—
|
—
|
|
Serum Concentration of VRC01 in Participants Assigned to Receive the mAb
8-week post infusion visit
|
4.7 μg/ml
Interval 1.5 to 6.0
|
8.3 μg/ml
Interval 2.3 to 16.7
|
—
|
—
|
|
Serum Concentration of VRC01 in Participants Assigned to Receive the mAb
Day 61
|
88.9 μg/ml
Interval 38.3 to 111.1
|
257.9 μg/ml
Interval 158.6 to 327.5
|
—
|
—
|
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=637 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=642 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=645 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=1287 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)
|
4.39 μg/ml
Interval 1.37 to 30.74
|
4.54 μg/ml
Interval 2.7 to 100.0
|
22.8 μg/ml
Interval 3.64 to 100.0
|
5.32 μg/ml
Interval 2.96 to 100.0
|
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=23 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)
ID80
|
NA titer
Interval to 12.77
Values below the limit of detection (less than 10) were set to NA.
|
—
|
—
|
—
|
|
VRC01 Serum Neutralization of Autologous Founder Viruses (ID50, ID80)
ID50
|
NA titer
Interval to 34.51
Values below the limit of detection (less than 10) were set to NA.
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 26 serious events
Other events: 594 other events
Deaths: 1 deaths
Low-Dose VRC01
Serious events: 10 serious events
Other events: 587 other events
Deaths: 2 deaths
High-Dose VRC01
Serious events: 23 serious events
Other events: 591 other events
Deaths: 0 deaths
Pooled VRC01
Serious events: 33 serious events
Other events: 1178 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=637 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=642 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=645 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=1287 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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Any Event in SOC
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Acute abdomen
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 acute
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Death
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.78%
5/637 • 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)
|
0.62%
4/642 • 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)
|
1.2%
8/645 • 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)
|
0.93%
12/1287 • 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
Abortion infected
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Arthritis gonococcal
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Complicated appendicitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Malaria
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.31%
4/1287 • 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
Meningitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Pelvic inflammatory disease
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Sepsis
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.93%
6/645 • 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)
|
0.62%
8/1287 • 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
Ankle fracture
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 poisoning
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Forearm fracture
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Pelvic fracture
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Uterine injury
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Any Event in SOC
|
1.1%
7/637 • 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)
|
0.47%
3/642 • 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%
5/645 • 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)
|
0.62%
8/1287 • 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)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
False labour
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.16%
1/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 embolism
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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=637 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=642 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=645 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=1287 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.
|
|---|---|---|---|---|
|
Infections and infestations
Cystitis
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Dermatitis infected
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
1.4%
9/637 • 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)
|
2.2%
14/642 • 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)
|
0.78%
5/645 • 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)
|
1.5%
19/1287 • 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)
|
|
Infections and infestations
Dermatophytosis of nail
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • 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
Diarrhoea infectious
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 fungal
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 escherichia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Dandruff
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
1.7%
11/637 • 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)
|
0.93%
6/642 • 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%
5/645 • 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)
|
0.85%
11/1287 • 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
Endometritis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.78%
5/637 • 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)
|
0.93%
6/642 • 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)
|
1.7%
11/645 • 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%
17/1287 • 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
Gastritis viral
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
9.1%
58/637 • Number of events 69 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
9.5%
61/642 • 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)
|
8.1%
52/645 • Number of events 67 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
8.8%
113/1287 • Number of events 139 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 abscess
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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 pyelonephritis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Eye abscess
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Eye infection
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 folliculitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • 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)
|
0.23%
3/1287 • 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
Folliculitis
|
1.7%
11/637 • 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)
|
2.8%
18/642 • 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)
|
2.2%
14/645 • 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%
32/1287 • 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)
|
|
Infections and infestations
Fungal infection
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Fungal skin infection
|
2.7%
17/637 • 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)
|
2.2%
14/642 • 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)
|
0.93%
6/645 • 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)
|
1.6%
20/1287 • 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)
|
|
Infections and infestations
Gonococcal infection
|
0.47%
3/637 • 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)
|
0.47%
3/642 • 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)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the 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%
5/1287 • 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
Gonorrhoea
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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%
5/1287 • 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
Groin abscess
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Helminthic infection
|
0.63%
4/637 • 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)
|
0.62%
4/642 • 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)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
6/1287 • 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 B
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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 herpes
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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%
5/1287 • 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
Genital herpes simplex
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 ulcer syndrome
|
0.63%
4/637 • 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)
|
1.6%
10/642 • 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)
|
0.62%
4/645 • 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%
14/1287 • 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
Genitourinary chlamydia infection
|
20.6%
131/637 • Number of events 166 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
22.4%
144/642 • 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)
|
22.9%
148/645 • Number of events 193 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
22.7%
292/1287 • Number of events 365 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
7.8%
50/637 • 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)
|
9.2%
59/642 • 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)
|
8.4%
54/645 • 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)
|
8.8%
113/1287 • Number of events 135 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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%
5/1287 • 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
Impetigo
|
0.78%
5/637 • 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)
|
0.62%
4/642 • 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)
|
0.62%
4/645 • 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)
|
0.62%
8/1287 • 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
Genitourinary tract infection
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/642 • 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)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
6/1287 • 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
Infected skin ulcer
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.78%
5/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Oropharyngeal candidiasis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.63%
4/637 • 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)
|
0.62%
4/642 • 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%
5/645 • 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)
|
0.70%
9/1287 • 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
Otitis media
|
1.3%
8/637 • 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)
|
1.6%
10/642 • 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%
9/645 • 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)
|
1.5%
19/1287 • 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)
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.31%
2/645 • 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%
5/1287 • 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
Otitis media chronic
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Pelvic abscess
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Pelvic inflammatory disease
|
2.4%
15/637 • 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%
10/642 • 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%
12/645 • 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%
22/1287 • 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
Perineal abscess
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Periorbital cellulitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
4.2%
27/637 • 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)
|
3.4%
22/642 • 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)
|
5.6%
36/645 • 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)
|
4.5%
58/1287 • Number of events 69 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Pharyngotonsillitis
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.47%
3/645 • 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)
|
0.47%
6/1287 • 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
Post procedural infection
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.23%
3/1287 • 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
Influenza
|
0.94%
6/637 • 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)
|
0.78%
5/642 • 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)
|
0.93%
6/645 • 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)
|
0.85%
11/1287 • 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
Joint abscess
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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)
|
0.31%
4/1287 • 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
Laryngitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 bacterial
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Pulpitis dental
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Lower respiratory tract infection
|
2.7%
17/637 • 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)
|
2.5%
16/642 • 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%
11/645 • 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)
|
2.1%
27/1287 • 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
Pyelonephritis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Lower respiratory tract infection bacterial
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Malaria
|
3.6%
23/637 • 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)
|
2.3%
15/642 • 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)
|
2.6%
17/645 • 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)
|
2.5%
32/1287 • 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)
|
|
Infections and infestations
Mastitis
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Molluscum contagiosum
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Mumps
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
3.1%
20/637 • 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)
|
2.8%
18/642 • 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)
|
2.6%
17/645 • 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)
|
2.7%
35/1287 • 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
Oral candidiasis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
1.9%
12/637 • 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)
|
0.78%
5/642 • 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%
8/645 • 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%
13/1287 • 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)
|
|
Infections and infestations
Oral viral infection
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 manuum
|
0.47%
3/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • 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
Tinea pedis
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Tinea versicolour
|
2.0%
13/637 • 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)
|
1.4%
9/642 • 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)
|
1.6%
10/645 • 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)
|
1.5%
19/1287 • 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
Tonsillitis
|
4.9%
31/637 • 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)
|
6.1%
39/642 • 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)
|
7.8%
50/645 • 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)
|
6.9%
89/1287 • Number of events 110 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises 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%
9/642 • 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)
|
0.47%
3/645 • 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)
|
0.93%
12/1287 • 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
Tooth abscess
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.47%
3/645 • 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)
|
0.47%
6/1287 • 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
Trichomoniasis
|
0.94%
6/637 • 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)
|
0.78%
5/642 • 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)
|
0.93%
6/645 • 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)
|
0.85%
11/1287 • 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
Typhoid fever
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Upper respiratory tract infection
|
25.1%
160/637 • Number of events 276 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
29.0%
186/642 • Number of events 315 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
26.2%
169/645 • Number of events 300 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
27.6%
355/1287 • Number of events 615 • The AE reporting period for this study comprises 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
|
0.78%
5/637 • 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)
|
0.93%
6/642 • 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%
5/645 • 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)
|
0.85%
11/1287 • 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
Urethritis
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Urethritis chlamydial
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
13.7%
87/637 • Number of events 116 • The AE reporting period for this study comprises 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%
88/642 • Number of events 119 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
14.9%
96/645 • Number of events 131 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
14.3%
184/1287 • Number of events 250 • The AE reporting period for this study comprises 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
|
1.6%
10/637 • 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)
|
1.6%
10/642 • 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)
|
1.4%
9/645 • 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)
|
1.5%
19/1287 • 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)
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 staphylococcal
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Urogenital infection fungal
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Urogenital trichomoniasis
|
1.3%
8/637 • 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)
|
3.1%
20/642 • 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)
|
3.7%
24/645 • 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)
|
3.4%
44/1287 • Number of events 52 • The AE reporting period for this study comprises 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
Vaginal infection
|
0.78%
5/637 • 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)
|
1.4%
9/642 • 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%
5/645 • 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%
14/1287 • 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
Vaginitis chlamydial
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Varicella
|
0.63%
4/637 • 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%
5/642 • 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)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
6/1287 • 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
Viral infection
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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)
|
0.47%
6/1287 • 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
Viral rhinitis
|
1.3%
8/637 • 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)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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)
|
0.31%
4/1287 • 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
Viral upper respiratory tract infection
|
2.0%
13/637 • 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)
|
2.3%
15/642 • 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)
|
2.5%
16/645 • 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)
|
2.4%
31/1287 • 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)
|
|
Infections and infestations
Respiratory tract infection
|
1.9%
12/637 • 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)
|
1.9%
12/642 • 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)
|
1.4%
9/645 • 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)
|
1.6%
21/1287 • 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)
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/642 • 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)
|
0.93%
6/645 • 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%
10/1287 • 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
Rhinitis
|
1.9%
12/637 • 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%
11/642 • 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)
|
1.6%
10/645 • 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%
21/1287 • 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
Salmonellosis
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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)
|
0.31%
4/1287 • 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
Secondary syphilis
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the 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%
5/645 • 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)
|
0.54%
7/1287 • 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
Sinusitis
|
1.4%
9/637 • 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%
11/642 • 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)
|
0.93%
6/645 • 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)
|
1.3%
17/1287 • 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
Skin bacterial infection
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
2.0%
13/637 • 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%
15/642 • 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)
|
2.5%
16/645 • 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)
|
2.4%
31/1287 • 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)
|
|
Infections and infestations
Syphilis
|
1.6%
10/637 • 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%
13/642 • 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)
|
1.9%
12/645 • 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)
|
1.9%
25/1287 • 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
Syphilis genital
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Systemic bacterial infection
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Systemic infection
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 capitis
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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%
5/1287 • 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
Tinea faciei
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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)
|
0.31%
4/1287 • 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
Tinea infection
|
1.6%
10/637 • 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)
|
0.62%
4/642 • 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%
5/645 • 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)
|
0.70%
9/1287 • 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
Vulval abscess
|
0.31%
2/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the 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%
5/645 • 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)
|
0.47%
6/1287 • 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
Vulvovaginal candidiasis
|
8.0%
51/637 • Number of events 67 • The AE reporting period for this study comprises 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%
45/642 • 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)
|
8.1%
52/645 • 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)
|
7.5%
97/1287 • Number of events 112 • The AE reporting period for this study comprises 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 mycotic infection
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
1.3%
8/637 • 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%
7/642 • 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)
|
1.4%
9/645 • 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)
|
1.2%
16/1287 • 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
Vulvovaginitis gonococcal
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 trichomonal
|
5.7%
36/637 • 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)
|
5.9%
38/642 • 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)
|
7.8%
50/645 • Number of events 68 • The AE reporting period for this study comprises 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%
88/1287 • Number of events 122 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 sepsis
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Any Event in SOC
|
14.3%
91/637 • Number of events 103 • The AE reporting period for this study comprises 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%
99/642 • Number of events 136 • The AE reporting period for this study comprises 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%
85/645 • Number of events 101 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
14.3%
184/1287 • Number of events 237 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.78%
5/637 • 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%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.94%
6/637 • 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)
|
2.2%
14/642 • 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)
|
0.93%
6/645 • 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)
|
1.6%
20/1287 • 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)
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises 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%
7/642 • 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)
|
0.47%
3/645 • 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%
10/1287 • 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)
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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)
|
0.31%
4/1287 • 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
Eye injury
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.93%
6/645 • 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)
|
0.62%
8/1287 • 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
Foot fracture
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.23%
3/1287 • 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
Forearm fracture
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Foreign body in eye
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Foreign body in reproductive tract
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.93%
6/642 • 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)
|
0.31%
2/645 • 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)
|
0.62%
8/1287 • 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
Incision site pain
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Induced abortion haemorrhage
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
1.4%
9/637 • 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)
|
3.4%
22/642 • 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)
|
2.3%
15/645 • 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)
|
2.9%
37/1287 • 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)
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Injury
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Jaw fracture
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.94%
6/637 • 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)
|
0.47%
3/642 • 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)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Ligament injury
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.93%
6/642 • 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)
|
0.47%
3/645 • 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)
|
0.70%
9/1287 • 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)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.94%
6/637 • 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%
5/642 • 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%
7/645 • 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)
|
0.93%
12/1287 • 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
Lower limb fracture
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Mouth injury
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Muscle strain
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Musculoskeletal injury
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 haemorrhage
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 inflammation
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 swelling
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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-traumatic pain
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Procedural dizziness
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
1.4%
9/637 • 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%
5/642 • 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%
7/645 • 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)
|
0.93%
12/1287 • 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
Skin abrasion
|
0.94%
6/637 • 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)
|
0.47%
3/642 • 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)
|
0.62%
4/645 • 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)
|
0.54%
7/1287 • 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)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.94%
6/637 • 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)
|
0.93%
6/642 • 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)
|
0.62%
4/645 • 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%
10/1287 • 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
Skin wound
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Soft tissue injury
|
1.3%
8/637 • 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%
8/642 • 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%
9/645 • 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)
|
1.3%
17/1287 • 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)
|
|
Injury, poisoning and procedural complications
Splinter
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Stab wound
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
1.4%
9/637 • 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)
|
0.93%
6/642 • 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)
|
0.47%
3/645 • 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)
|
0.70%
9/1287 • 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
Lip injury
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
2.2%
14/637 • 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)
|
3.3%
21/642 • 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)
|
2.2%
14/645 • 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)
|
2.7%
35/1287 • 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)
|
|
Infections and infestations
Cutaneous larva migrans
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.78%
5/637 • 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%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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%
12/637 • 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)
|
2.3%
15/642 • 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)
|
2.6%
17/645 • 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)
|
2.5%
32/1287 • 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)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.47%
3/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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%
5/1287 • 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)
|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Hypochromic anaemia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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)
|
0.47%
6/1287 • 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)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/642 • 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)
|
0.47%
3/645 • 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)
|
0.54%
7/1287 • 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)
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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)
|
0.47%
6/1287 • 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)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Neutropenia
|
0.31%
2/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Neutrophilia
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Normochromic anaemia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Normocytic anaemia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • 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%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • 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)
|
|
Cardiac disorders
Any Event in SOC
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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%
5/645 • 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)
|
0.62%
8/1287 • 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)
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.47%
3/645 • 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)
|
0.47%
6/1287 • 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
Tachycardia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
1.6%
10/637 • 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%
8/642 • 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%
9/645 • 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)
|
1.3%
17/1287 • 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)
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.78%
5/637 • 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%
5/642 • 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%
5/645 • 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%
10/1287 • 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)
|
|
Ear and labyrinth disorders
External ear pain
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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)
|
|
Eye disorders
Any Event in SOC
|
6.6%
42/637 • Number of events 52 • The AE reporting period for this study comprises 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%
25/642 • 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)
|
3.9%
25/645 • 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)
|
3.9%
50/1287 • 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)
|
|
Eye disorders
Asthenopia
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Astigmatism
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
3.0%
19/637 • 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)
|
2.5%
16/642 • 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%
11/645 • 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)
|
2.1%
27/1287 • 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)
|
|
Eye disorders
Diplopia
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 discharge
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.78%
5/637 • 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)
|
0.47%
3/642 • 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)
|
0.47%
3/645 • 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)
|
0.47%
6/1287 • 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)
|
|
Eye disorders
Eye pruritus
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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%
5/645 • 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)
|
0.62%
8/1287 • 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)
|
|
Eye disorders
Eye swelling
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Eyelids pruritus
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Gaze palsy
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Hypermetropia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Night blindness
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Periorbital pain
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Periorbital swelling
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Photophobia
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Presbyopia
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Pterygium
|
0.47%
3/637 • 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%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Refraction disorder
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Visual impairment
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
34.5%
220/637 • Number of events 325 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
25.1%
161/642 • Number of events 273 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
29.5%
190/645 • Number of events 309 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
27.3%
351/1287 • Number of events 582 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.23%
3/1287 • 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 distension
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
7.7%
49/637 • 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)
|
4.0%
26/642 • 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)
|
4.7%
30/645 • 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)
|
4.4%
56/1287 • 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)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.0%
32/637 • 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)
|
2.6%
17/642 • 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)
|
4.2%
27/645 • 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)
|
3.4%
44/1287 • 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)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
9/637 • 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%
7/642 • 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)
|
1.1%
7/645 • 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)
|
1.1%
14/1287 • 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)
|
|
Gastrointestinal disorders
Anal fissure
|
0.63%
4/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Anal pruritus
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Angular cheilitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • 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%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • 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)
|
|
Gastrointestinal disorders
Constipation
|
2.8%
18/637 • 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%
11/642 • 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)
|
2.8%
18/645 • 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)
|
2.3%
29/1287 • 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)
|
|
Gastrointestinal disorders
Dental caries
|
1.1%
7/637 • 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)
|
1.7%
11/642 • 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%
9/645 • 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)
|
1.6%
20/1287 • 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)
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
34/637 • 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)
|
4.2%
27/642 • 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)
|
5.7%
37/645 • 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)
|
5.0%
64/1287 • 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)
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
4.1%
26/637 • 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)
|
5.3%
34/642 • 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)
|
4.7%
30/645 • 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)
|
5.0%
64/1287 • 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)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Eructation
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Faecaloma
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
3.8%
24/637 • 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)
|
3.4%
22/642 • 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)
|
4.5%
29/645 • 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)
|
4.0%
51/1287 • 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)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
1.7%
11/637 • 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%
13/642 • 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%
14/645 • 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%
27/1287 • 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)
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Glossitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Glossodynia
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
1.1%
7/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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%
5/1287 • 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
Hyperaesthesia teeth
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Hyperchlorhydria
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.93%
6/642 • 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)
|
0.47%
3/645 • 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)
|
0.70%
9/1287 • 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)
|
|
Gastrointestinal disorders
Lip blister
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.93%
6/642 • 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)
|
0.47%
3/645 • 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)
|
0.70%
9/1287 • 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
Nausea
|
3.0%
19/637 • 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)
|
2.0%
13/642 • 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%
15/645 • 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)
|
2.2%
28/1287 • 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)
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 mucosal blistering
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Peptic ulcer
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 mass
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 geographic
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
3.1%
20/637 • 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)
|
3.1%
20/642 • 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)
|
3.1%
20/645 • 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)
|
3.1%
40/1287 • 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)
|
|
Gastrointestinal disorders
Trichoglossia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Umbilical hernia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Vomiting
|
1.9%
12/637 • 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)
|
0.93%
6/642 • 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%
8/645 • 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%
14/1287 • 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)
|
|
General disorders
Any Event in SOC
|
20.6%
131/637 • Number of events 186 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
21.3%
137/642 • 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)
|
20.3%
131/645 • Number of events 185 • The AE reporting period for this study comprises 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%
268/1287 • Number of events 396 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the 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%
5/645 • 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)
|
0.54%
7/1287 • 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)
|
|
General disorders
Asthenia
|
0.47%
3/637 • 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%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • 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)
|
|
General disorders
Chest pain
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.31%
4/1287 • 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
Chills
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Facial pain
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.31%
2/642 • 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%
5/645 • 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)
|
0.54%
7/1287 • 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)
|
|
General disorders
Feeling hot
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Implant site pain
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
15.7%
100/637 • Number of events 142 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
17.4%
112/642 • Number of events 176 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
14.6%
94/645 • Number of events 134 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
16.0%
206/1287 • Number of events 310 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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)
|
|
General disorders
Mass
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
1.4%
9/637 • 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)
|
1.6%
10/642 • 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)
|
1.6%
10/645 • 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)
|
1.6%
20/1287 • 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)
|
|
General disorders
Oedema peripheral
|
0.31%
2/637 • 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%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.63%
4/637 • 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%
5/642 • 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%
7/645 • 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)
|
0.93%
12/1287 • 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
Peripheral swelling
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the 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%
5/645 • 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)
|
0.54%
7/1287 • 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)
|
|
General disorders
Suprapubic pain
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 pruritus
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 swelling
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • 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)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • 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)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Fatty liver alcoholic
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • 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%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • 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)
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Hepatomegaly
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
1.6%
10/642 • 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)
|
1.1%
7/645 • 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)
|
1.3%
17/1287 • 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)
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Atopy
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Food allergy
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.47%
3/645 • 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)
|
0.47%
6/1287 • 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
Seasonal allergy
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
74.4%
474/637 • Number of events 1458 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
74.9%
481/642 • Number of events 1535 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
75.5%
487/645 • Number of events 1560 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
75.2%
968/1287 • Number of events 3095 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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 wall abscess
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Abscess limb
|
1.7%
11/637 • 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)
|
1.4%
9/642 • 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%
5/645 • 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%
14/1287 • 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
Abscess of eyelid
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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 oral
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
1.4%
9/637 • 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)
|
3.0%
19/642 • 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)
|
2.2%
14/645 • 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)
|
2.6%
33/1287 • 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 sinusitis
|
0.47%
3/637 • 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%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Alveolar osteitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Bacterial diarrhoea
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 food poisoning
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
3.5%
22/637 • 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)
|
2.3%
15/642 • 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)
|
3.1%
20/645 • 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)
|
2.7%
35/1287 • 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)
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • 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)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Blister infected
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
5.0%
32/637 • Number of events 41 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
3.7%
24/642 • 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)
|
2.9%
19/645 • 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)
|
3.3%
43/1287 • 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)
|
|
Infections and infestations
Breast abscess
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Bronchitis
|
2.2%
14/637 • 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%
7/642 • 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%
7/645 • 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%
14/1287 • 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)
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Bullous impetigo
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Candida infection
|
0.47%
3/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Carbuncle
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Cellulitis
|
1.3%
8/637 • 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%
5/642 • 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)
|
0.62%
4/645 • 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)
|
0.70%
9/1287 • 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
Cervicitis
|
0.16%
1/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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%
5/1287 • 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
Chlamydial infection
|
1.1%
7/637 • 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)
|
0.93%
6/642 • 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)
|
0.93%
6/645 • 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)
|
0.93%
12/1287 • 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
Complicated appendicitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 ulcer
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
37.0%
236/637 • Number of events 436 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
34.3%
220/642 • Number of events 372 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
35.2%
227/645 • Number of events 406 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
34.7%
447/1287 • Number of events 778 • The AE reporting period for this study comprises 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
|
9.4%
60/637 • Number of events 88 • The AE reporting period for this study comprises 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%
39/642 • 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)
|
9.1%
59/645 • 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)
|
7.6%
98/1287 • Number of events 129 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
1.3%
8/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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%
5/1287 • 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)
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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)
|
|
Investigations
Bilirubin urine present
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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)
|
|
Investigations
Blood creatinine increased
|
13.8%
88/637 • Number of events 133 • The AE reporting period for this study comprises 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%
91/642 • 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)
|
14.9%
96/645 • Number of events 126 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
14.5%
187/1287 • Number of events 247 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • 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)
|
0.16%
2/1287 • 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)
|
|
Investigations
Blood pressure decreased
|
0.47%
3/637 • 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)
|
1.2%
8/642 • 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%
5/645 • 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%
13/1287 • 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)
|
|
Investigations
Blood pressure increased
|
6.3%
40/637 • 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)
|
7.3%
47/642 • 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)
|
6.7%
43/645 • 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)
|
7.0%
90/1287 • Number of events 139 • The AE reporting period for this study comprises 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 decreased
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
CD4 lymphocytes decreased
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Carbon dioxide decreased
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Fungal test positive
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Gamma-glutamyltransferase increased
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
6.6%
42/637 • 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)
|
6.7%
43/642 • 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%
39/645 • Number of events 69 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
6.4%
82/1287 • Number of events 135 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.47%
3/642 • 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)
|
0.47%
3/645 • 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)
|
0.47%
6/1287 • 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)
|
|
Investigations
Neutrophil count decreased
|
3.5%
22/637 • 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)
|
1.4%
9/642 • 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%
13/645 • 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%
22/1287 • 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)
|
|
Investigations
Platelet count decreased
|
2.4%
15/637 • 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)
|
1.6%
10/642 • 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%
10/645 • 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%
20/1287 • 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)
|
|
Investigations
Protein urine present
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 count increased
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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 positive
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Serum ferritin decreased
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Smear vaginal abnormal
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Weight decreased
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the 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%
5/642 • 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)
|
0.62%
4/645 • 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)
|
0.70%
9/1287 • 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)
|
|
Investigations
Weight increased
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.63%
4/637 • 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)
|
0.31%
2/642 • 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)
|
0.62%
4/645 • 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)
|
0.47%
6/1287 • 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
White blood cell count increased
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
5.2%
33/637 • 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)
|
5.3%
34/642 • 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)
|
7.1%
46/645 • 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)
|
6.2%
80/1287 • 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)
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.78%
5/637 • 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%
10/642 • 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)
|
1.9%
12/645 • 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%
22/1287 • 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)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.0%
19/637 • 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)
|
3.1%
20/642 • 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)
|
3.4%
22/645 • 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)
|
3.3%
42/1287 • 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)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Hyperphagia
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Increased appetite
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Iron deficiency
|
1.1%
7/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises 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%
9/645 • 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)
|
0.85%
11/1287 • 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)
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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 B12 deficiency
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
21.2%
135/637 • Number of events 191 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
18.2%
117/642 • Number of events 170 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
20.5%
132/645 • Number of events 186 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
19.3%
249/1287 • Number of events 356 • The AE reporting period for this study comprises 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
|
4.9%
31/637 • 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)
|
3.6%
23/642 • 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)
|
3.6%
23/645 • 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)
|
3.6%
46/1287 • 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)
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
9.6%
61/637 • 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)
|
7.9%
51/642 • 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)
|
8.5%
55/645 • 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)
|
8.2%
106/1287 • Number of events 137 • The AE reporting period for this study comprises 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
Bone pain
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Bone swelling
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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%
5/1287 • 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
Fibromyalgia
|
0.31%
2/637 • 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)
|
0.47%
3/642 • 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%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Flank pain
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
1.3%
8/637 • 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)
|
0.62%
4/642 • 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)
|
0.47%
3/645 • 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)
|
0.54%
7/1287 • 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)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
1.4%
9/637 • 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%
13/642 • 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)
|
1.9%
12/645 • 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%
25/1287 • 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)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
2.2%
14/637 • 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%
11/642 • 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)
|
2.5%
16/645 • 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)
|
2.1%
27/1287 • 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)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
2.2%
14/637 • 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)
|
1.6%
10/642 • 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)
|
2.3%
15/645 • 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)
|
1.9%
25/1287 • 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)
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 mass
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
1.3%
8/637 • 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%
8/642 • 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)
|
0.93%
6/645 • 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%
14/1287 • 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)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
2.0%
13/637 • 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)
|
1.9%
12/642 • 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)
|
3.3%
21/645 • 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%
33/1287 • 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
Pain in jaw
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Polyarthritis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Synovial cyst
|
0.47%
3/637 • 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%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
1.1%
7/637 • 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)
|
0.62%
4/642 • 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%
7/645 • 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)
|
0.85%
11/1287 • 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)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.31%
2/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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)
Uterine leiomyoma
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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)
Vulvovaginal warts
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.31%
4/1287 • 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
Any Event in SOC
|
24.5%
156/637 • Number of events 223 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
22.6%
145/642 • Number of events 206 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
22.2%
143/645 • Number of events 220 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
22.4%
288/1287 • Number of events 426 • The AE reporting period for this study comprises 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
|
4.1%
26/637 • 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)
|
2.8%
18/642 • 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%
17/645 • 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)
|
2.7%
35/1287 • Number of events 41 • The AE reporting period for this study comprises 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
Facial paralysis
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
19.0%
121/637 • Number of events 167 • The AE reporting period for this study comprises 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%
123/642 • Number of events 162 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
18.3%
118/645 • Number of events 182 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
18.7%
241/1287 • Number of events 344 • The AE reporting period for this study comprises 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
Hypersomnia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Hyposmia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Meningism
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.94%
6/637 • 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%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/645 • 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)
|
0.31%
4/1287 • 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
Neuropathy peripheral
|
0.47%
3/637 • 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)
|
0.47%
3/642 • 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%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Peripheral sensory neuropathy
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 disturbance
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Syncope
|
0.63%
4/637 • 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)
|
0.31%
2/642 • 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)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Tension headache
|
0.78%
5/637 • 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)
|
0.93%
6/642 • 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%
9/645 • 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%
15/1287 • 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
Tremor
|
0.31%
2/637 • 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%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Ulnar nerve palsy
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Any Event in SOC
|
0.94%
6/637 • 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)
|
1.6%
10/642 • 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)
|
2.0%
13/645 • 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)
|
1.8%
23/1287 • 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)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion complete
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.47%
3/637 • 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)
|
1.2%
8/642 • 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%
11/645 • 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)
|
1.5%
19/1287 • 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)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Complication of pregnancy
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Morning sickness
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Retained products of conception
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
2.7%
17/637 • 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)
|
2.8%
18/642 • 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)
|
3.1%
20/645 • 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)
|
3.0%
38/1287 • 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)
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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%
5/645 • 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)
|
0.62%
8/1287 • 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)
|
|
Psychiatric disorders
Depressed mood
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the 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%
5/642 • 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)
|
0.47%
3/645 • 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)
|
0.62%
8/1287 • 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
Emotional distress
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.78%
5/637 • 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)
|
0.62%
4/642 • 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)
|
0.93%
6/645 • 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)
|
0.78%
10/1287 • 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)
|
|
Psychiatric disorders
Libido decreased
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Loss of libido
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Pica
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Psychogenic pseudosyncope
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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%
5/1287 • 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
Suicidal ideation
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Terminal insomnia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
9.9%
63/637 • Number of events 86 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
12.5%
80/642 • 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)
|
9.3%
60/645 • 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)
|
10.9%
140/1287 • Number of events 175 • The AE reporting period for this study comprises 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
Crystalluria
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 interstitial
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
2.2%
14/637 • 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)
|
1.6%
10/642 • 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)
|
1.2%
8/645 • 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)
|
1.4%
18/1287 • 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)
|
|
Renal and urinary disorders
Glycosuria
|
0.47%
3/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.31%
4/1287 • 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)
|
|
Renal and urinary disorders
Haematuria
|
1.9%
12/637 • 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)
|
4.4%
28/642 • 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)
|
1.9%
12/645 • 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)
|
3.1%
40/1287 • Number of events 41 • The AE reporting period for this study comprises 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
Ketonuria
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Nocturia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Polyuria
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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)
|
|
Renal and urinary disorders
Proteinuria
|
6.6%
42/637 • 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)
|
8.1%
52/642 • 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)
|
5.7%
37/645 • 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)
|
6.9%
89/1287 • Number of events 98 • The AE reporting period for this study comprises 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
Urge incontinence
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
27.3%
174/637 • Number of events 262 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
27.1%
174/642 • Number of events 246 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
22.0%
142/645 • Number of events 205 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
24.6%
316/1287 • Number of events 451 • The AE reporting period for this study comprises 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
Abnormal uterine bleeding
|
7.5%
48/637 • 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)
|
6.9%
44/642 • 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)
|
7.4%
48/645 • 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)
|
7.1%
92/1287 • Number of events 123 • The AE reporting period for this study comprises 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
Adnexa uteri cyst
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Adnexa uteri mass
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Adnexa uteri pain
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.23%
3/1287 • 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
Bartholin's cyst
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • 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
Breast discharge
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Breast mass
|
0.47%
3/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.31%
4/1287 • 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
Breast pain
|
1.1%
7/637 • 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)
|
1.2%
8/642 • 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%
5/645 • 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)
|
1.0%
13/1287 • 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)
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Breast tenderness
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Cervical dysplasia
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Coital bleeding
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
2.4%
15/637 • 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)
|
2.3%
15/642 • 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%
7/645 • 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)
|
1.7%
22/1287 • 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)
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.31%
4/1287 • 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
Galactorrhoea
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 blister
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 pain
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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)
|
0.47%
3/642 • 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)
|
0.47%
3/645 • 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)
|
0.47%
6/1287 • 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
Heavy menstrual bleeding
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/642 • 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)
|
0.62%
4/645 • 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)
|
0.62%
8/1287 • 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)
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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
Menometrorrhagia
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Ovarian cyst
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
1.4%
9/637 • 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%
5/642 • 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%
5/645 • 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%
10/1287 • 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)
|
|
Reproductive system and breast disorders
Perineal rash
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Polymenorrhoea
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • 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)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Uterine cyst
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Uterine pain
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Vaginal discharge
|
15.2%
97/637 • Number of events 126 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
14.0%
90/642 • Number of events 114 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
10.9%
70/645 • 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)
|
12.4%
160/1287 • Number of events 201 • The AE reporting period for this study comprises 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 haemorrhage
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Vaginal ulceration
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Vulval ulceration
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Vulvovaginal pruritus
|
1.6%
10/637 • 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)
|
0.93%
6/642 • 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%
7/645 • 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%
13/1287 • 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)
|
|
Reproductive system and breast disorders
Vulvovaginal rash
|
0.47%
3/637 • 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)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Vulvovaginal swelling
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Vulvovaginal ulceration
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Withdrawal bleed
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
11.1%
71/637 • Number of events 83 • The AE reporting period for this study comprises 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%
57/642 • 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)
|
7.6%
49/645 • 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)
|
8.2%
106/1287 • Number of events 120 • The AE reporting period for this study comprises 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 cough
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
6.3%
40/637 • 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)
|
3.3%
21/642 • 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)
|
3.4%
22/645 • 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)
|
3.3%
43/1287 • Number of events 47 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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)
|
0.31%
4/1287 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.62%
4/642 • 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)
|
0.47%
3/645 • 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)
|
0.54%
7/1287 • 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
Lower respiratory tract congestion
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
1.3%
8/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.93%
6/645 • 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)
|
0.62%
8/1287 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
10/637 • 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%
11/642 • 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%
7/645 • 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%
18/1287 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Rhinitis allergic
|
1.3%
8/637 • 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)
|
1.6%
10/642 • 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%
5/645 • 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%
15/1287 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Sneezing
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
19.0%
121/637 • 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)
|
22.3%
143/642 • Number of events 190 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
19.4%
125/645 • Number of events 173 • The AE reporting period for this study comprises 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%
268/1287 • Number of events 363 • The AE reporting period for this study comprises 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
|
1.7%
11/637 • 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)
|
0.93%
6/642 • 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)
|
1.7%
11/645 • 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)
|
1.3%
17/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 acneiform
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
1.1%
7/637 • 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)
|
1.2%
8/642 • 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%
8/645 • 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%
16/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.47%
3/637 • 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)
|
0.62%
4/642 • 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)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the 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%
5/1287 • 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
Dermatitis bullous
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.94%
6/637 • 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)
|
0.93%
6/642 • 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)
|
1.9%
12/645 • 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%
18/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Dyshidrotic eczema
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
1.4%
9/637 • 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%
13/642 • 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)
|
1.6%
10/645 • 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)
|
1.8%
23/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Hidradenitis
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.47%
3/637 • 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%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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)
|
0.47%
3/645 • 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)
|
0.47%
6/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.31%
2/637 • 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)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/645 • 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%
5/1287 • 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
Pityriasis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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 alba
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
3.9%
25/637 • 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)
|
5.1%
33/642 • 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)
|
3.6%
23/645 • 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)
|
4.4%
56/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.5%
22/637 • 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%
19/642 • 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)
|
2.5%
16/645 • 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)
|
2.7%
35/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Rash macular
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • 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)
|
0.23%
3/1287 • 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 maculo-papular
|
0.31%
2/637 • 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)
|
0.62%
4/642 • 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)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
6/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.2%
14/637 • 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%
14/642 • 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)
|
2.5%
16/645 • 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)
|
2.3%
30/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.94%
6/637 • 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%
7/642 • 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%
8/645 • 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%
15/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
Scar pain
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 2 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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 hypopigmentation
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • 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
Skin ulcer
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.47%
3/642 • 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%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.23%
3/1287 • 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
Solar dermatitis
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • 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
Urticaria
|
0.47%
3/637 • 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)
|
2.5%
16/642 • 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)
|
2.9%
19/645 • 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)
|
2.7%
35/1287 • 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)
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
0.16%
1/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Vitiligo
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Any Event in SOC
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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)
|
|
Social circumstances
Victim of sexual abuse
|
0.31%
2/637 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/642 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
4/1287 • 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)
|
|
Surgical and medical procedures
Any Event in SOC
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
|
Surgical and medical procedures
Finger amputation
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
|
0.78%
5/637 • 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)
|
1.9%
12/642 • 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%
13/645 • 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%
25/1287 • 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)
|
|
Vascular disorders
Haematoma
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/645 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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
|
0.63%
4/637 • 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)
|
1.6%
10/642 • 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)
|
1.6%
10/645 • 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)
|
1.6%
20/1287 • 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)
|
|
Vascular disorders
Phlebitis
|
0.16%
1/637 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/1287 • The AE reporting period for this study comprises 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
Thrombophlebitis superficial
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
1/642 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/645 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.08%
1/1287 • Number of events 1 • The AE reporting period for this study comprises 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
Vascular pain
|
0.00%
0/637 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.00%
0/642 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.31%
2/645 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from study enrollment until study completion at the week 104 visit or discontinuation of the study)
|
0.16%
2/1287 • Number of events 2 • The AE reporting period for this study comprises 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